chicago_biz
4 records
Chicago License: SIEMENS MEDICAL SOLUTIONS USA INC
Limited Business License | Operation of an Administrative Commercial Office
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Chicago License: SIEMENS MEDICAL SOLUTIONS USA INC
Limited Business License | Operation of an Administrative Commercial Office
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Chicago License: SIEMENS MEDICAL SOLUTIONS USA INC
Limited Business License | Operation of an Administrative Commercial Office
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Chicago License: SIEMENS MEDICAL SOLUTIONS USA INC
Limited Business License | Operation of an Administrative Commercial Office
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co_sos
1 records
CO Business: SIEMENS MEDICAL SOLUTIONS USA, INC.
1987-08-04
FPC | Status: Good Standing | Malvern, PA
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epa_echo
1 records
fda
607 records
FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20260204
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image o | Product: Interventional Fluoroscopic X-Ray Syst...
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FDA Device Recall: NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo
2026-02-11
Class II — To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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FDA Device Recall: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT
2026-02-11
Class II — To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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FDA Device Recall: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material N
2026-02-04
Class II — Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
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FDA Device Recall: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
2026-01-14
Class II — A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switc...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class I
20251008
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unab | Product: MAGNETOM Skyra (DE). Model Number: 104...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class I
20251008
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unab | Product: Biograph mMR. Model Number: 10433372.
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FDA Device Recall: MAMMOMAT Inspiration;
2025-12-10
Class II — There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for...
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FDA Device Recall: MAMMOMAT Fusion;
2025-12-10
Class II — There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for...
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FDA Device Recall: MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: Biograph mMR. Model Number: 10433372.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Verio. Model Number: 10276755.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Lumina (DE). Model Number: 11344916.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Vida Fit. Model Number: 11410481.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Skyra fit. Model Number: 10849580.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Cima.X (DE). Model Number: 11647158.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
2025-10-08
Class I — There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed ventin...
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FDA Device Recall: Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
2025-09-17
Class II — Limited system movements after startup .
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FDA Device Recall: interventional fluoroscopic x-ray system
2025-07-09
Class II — In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly rep...
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FDA Device Recall: interventional fluoroscopic x-ray system
2025-07-09
Class II — In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly rep...
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FDA Device Recall: interventional fluoroscopic x-ray system
2025-07-09
Class II — In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly rep...
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FDA Device Recall: UROSKOP Omnia Max. Model Number: 10762473
2025-06-25
Class II — A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
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FDA Device Recall: ARTIS One Angiographic X-Ray System
2025-02-05
Class II — A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltrati...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20240117
The possibility of the Sensis documentation functionality application to crash. | Product: Sensis Vibe Hemo
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FDA Device Recall: ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791,
2024-10-02
Class II — If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perfor...
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FDA Device Recall: ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. AC
2024-10-02
Class II — If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perfor...
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FDA Device Recall: ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with so
2024-10-02
Class II — If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perfor...
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FDA Device Recall: LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an
2024-08-14
Class II — The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
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FDA Device Recall: Luminos Agile Max -Intended to visualize anatomical structures by converting an
2024-08-14
Class II — The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
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FDA Device Recall: Sensis Vibe systems with software version VD15B in combination with Sensis High
2024-07-31
Class II — If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exi...
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FDA Device Recall: Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL S
2024-07-31
Class II — If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exi...
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FDA Device Recall: Sensis Vibe systems with software version VD15B in combination with AXIOM Sensi
2024-07-31
Class II — If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exi...
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FDA Device Recall: AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining
2024-07-03
Class II — Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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FDA Device Recall: MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a pa
2024-07-03
Class II — Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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FDA Device Recall: ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software
2024-05-01
Class II — On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are ex...
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FDA Device Recall: ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, R
2024-05-01
Class II — On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are ex...
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FDA Device Recall: Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis z
2024-04-24
Class II — Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the mes...
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FDA Device Recall: Sensis Vibe Hemo
2024-01-17
Class II — The possibility of the Sensis documentation functionality application to crash.
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20231108
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems | Product: ***Updated 12/4/23*** (1) Cios Flow (V...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20230809
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than exp | Product: The following Pro.specta Emission Comp...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20230531
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect | Product: Luminos Agile Max (VE10, VF10, VF11)
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20230405
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, | Product: ARTIS pheno systems with a Siemens Hea...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20230301
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration param | Product: Luminos dRF Max with software VE10, VF...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20230125
Mechanical connection between the tabletop and table base may be lost. | Product: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
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FDA Device Recall: ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Syste
2023-11-08
Class II — Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiag...
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FDA Device Recall: Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for t
2023-11-08
Class II — Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiag...
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FDA Device Recall: (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM
2023-10-11
Class II — In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examination...
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FDA Device Recall: ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
2023-09-20
Class II — If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement ...
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FDA Device Recall: ARTIS pheno-Angiography systems developed for single and biplane diagnostic imag
2023-08-16
Class II — Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning ...
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FDA Device Recall: ARTIS icono floor-Angiography systems developed for single and biplane diagnosti
2023-08-16
Class II — Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning ...
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FDA Device Recall: The following Pro.specta Emission Computed Tomography Systems that were manufact
2023-08-09
Class II — During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 posi...
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FDA Device Recall: Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating r
2023-08-02
Class II — Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g.,...
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FDA Device Recall: Luminos Agile Max (VE10, VF10, VF11)
2023-05-31
Class II — Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the...
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FDA Device Recall: Luminos dRF Max (VE10, VF10, VF11)
2023-05-31
Class II — Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the...
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FDA Device Recall: ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OE
2023-05-10
Class II — If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned ou...
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FDA Device Recall: ARTIS one with a hybrid cable- An angiography system developed for diagnostic im
2023-05-03
Class II — Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
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FDA Device Recall: ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-
2023-04-05
Class II — In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
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FDA Device Recall: Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for
2023-03-01
Class II — Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to defaul...
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FDA Device Recall: Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ra
2023-03-01
Class II — Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to defaul...
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FDA Device Recall: Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ra
2023-03-01
Class II — Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to defaul...
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FDA Device Recall: Luminos Agile with software VC10 - A diagnostic imaging system for radiographic
2023-03-01
Class II — Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to defaul...
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FDA Device Recall: Luminos dRF with software VD10- A diagnostic imaging system for radiographic an
2023-03-01
Class II — Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to defaul...
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FDA Device Recall: SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R S
2023-02-22
Class II — This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
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FDA Device Recall: SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
2023-02-22
Class II — This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
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FDA Device Recall: System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis
2023-02-08
Class II — In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical...
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FDA Device Recall: Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow lice
2023-02-01
Class II — In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
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FDA Device Recall: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
2023-01-25
Class II — Mechanical connection between the tabletop and table base may be lost.
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FDA Device Recall: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
2023-01-25
Class II — There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. Th...
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FDA Device Recall: Programmable Diagnostic Computer
2023-01-11
Class II — The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220713
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may c | Product: Artis Icono, Interventional Fluoroscop...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220427
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficien | Product: Artis zee floor MN, Model Number 10094...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220427
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficien | Product: Artis Q ceiling, Model Number 10848281
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220427
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficien | Product: Artis Q zeego, Model Number 10848283
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220427
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficien | Product: Artis Q.zen floor, Model Number 108483...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220202
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement af | Product: Artis pheno with software VE20C- diag...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220119
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | Product: SOMATOM Edge Plus-Computed tomography system Model 1026700
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20220105
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver do | Product: ARTISTE with syngo RT Therapist-linear...
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FDA Device Recall: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1
2022-12-21
Class II — When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
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FDA Device Recall: Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
2022-09-07
Class II — Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detecti...
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FDA Device Recall: AXIOM Sensis or Sensis Vibe Combo systems as follows: System
2022-08-24
Class III — The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient tab...
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FDA Device Recall: Sensis with software version VD12A. A diagnostic and administrative tool suppo
2022-07-27
Class II — Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the ...
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FDA Device Recall: Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
2022-07-13
Class II — During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system du...
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FDA Device Recall: Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interv
2022-07-13
Class II — It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during star...
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FDA Device Recall: Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
2022-07-06
Class II — A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of...
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FDA Device Recall: Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
2022-05-04
Class II — Transducers (component of ultrasound system) may exceed recommended thermal index limits
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FDA Device Recall: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number
2022-05-04
Class II — Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Pat...
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FDA Device Recall: syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 104
2022-05-04
Class II — Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Pat...
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FDA Device Recall: Artis zee floor MN, Model Number 10094142
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis Q ceiling, Model Number 10848281
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis Q zeego, Model Number 10848283
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis Q.zen floor, Model Number 10848353
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis zee biplane, Model Number 10094141
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis zee multi-purpose, Model Number 10094139
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis zee biplane MN, Model Number 10094143
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 110
2022-04-27
Class II — Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during int...
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FDA Device Recall: Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MA
2022-04-27
Class II — Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors ...
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FDA Device Recall: Artis Q floor, Model Number 10848280
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf
2022-04-27
Class II — Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors ...
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FDA Device Recall: Artis zee ceiling, Model Number 10094137
2022-04-27
Class II — If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display ...
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FDA Device Recall: Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 1
2022-03-23
Class II — The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to sa...
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FDA Device Recall: Artis pheno with software VE20C- diagnostic imaging angiography system Model:
2022-02-02
Class II — Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, sys...
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FDA Device Recall: Artis icono biplane with software VE20C-diagnostic imaging angiography system M
2022-02-02
Class II — Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, sys...
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FDA Device Recall: Artis icono floor with software VE20C-diagnostic imaging angiography system Mod
2022-02-02
Class II — Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, sys...
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FDA Device Recall: 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, materi
2022-01-26
Class II — Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons a...
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FDA Device Recall: SOMATOM Edge Plus-Computed tomography system Model 1026700
2022-01-19
Class II — Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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FDA Device Recall: SOMATOM Definition AS-Computed tomography system Model 8098027
2022-01-19
Class II — Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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FDA Device Recall: SOMATOM Definition Edge -Computed tomography system Model 10590000
2022-01-19
Class II — Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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FDA Device Recall: SOMATOM Confidence -Computed tomography systems Model 10590100
2022-01-19
Class II — Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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FDA Device Recall: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray phot
2022-01-05
Class II — Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could r...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20210908
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment | Product: Artis Models with SW version VD12 liste...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20210120
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and | Product: SOMATOM Force, Definition AS, Definiti...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20210120
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Ove | Product: Artis zee/ zeego & Artis Q/ Q.zen Art...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20210120
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the mo | Product: Uroskop Omnia, Model no. 10094910 - Pr...
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FDA Device Recall: Artis Q.zen ceiling with software VD12-angiography systems developed for single
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: Artis Q floor with software VD12- angiography systems developed for single and b
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
2021-12-01
Class II — software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnos...
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FDA Device Recall: Artis Q biplane with software VD12-angiography systems developed for single and
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: Artis zee floor with software VD12-angiography systems developed for single and
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: Artis zee ceiling with software VD12-angiography systems developed for single an
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
2021-12-01
Class II — software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnos...
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FDA Device Recall: Artis Q.zen biplane with software VD12- angiography systems developed for single
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: Artis zee biplane with software VD12-angiography systems developed for single an
2021-12-01
Class II — If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result i...
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FDA Device Recall: SOMATOM Force with software syngo.CT VB20 Model #10742326
2021-12-01
Class II — software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnos...
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FDA Device Recall: Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5,
2021-09-29
Class II — Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional w...
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FDA Device Recall: syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMAT
2021-09-22
Class II — Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent ...
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FDA Device Recall: Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis
2021-09-08
Class II — Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
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FDA Device Recall: ARTIS pheno- angiography systems developed for single and biplane diagnostic ima
2021-07-14
Class II — Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended trave...
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FDA Device Recall: Artis systems - Product Usage: an angiography systems developed for single and b
2021-05-05
Class II — Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunctio...
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FDA Device Recall: Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS i
2021-05-05
Class II — Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
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FDA Device Recall: Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 100941
2021-05-05
Class II — Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment a...
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FDA Device Recall: Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System gen
2021-04-14
Class II — A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead...
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FDA Device Recall: Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz **
2021-04-07
Class II — The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, whi...
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FDA Device Recall: Interventional Fluoroscopic X-Ray System - Product Usage: developed for single a
2021-03-31
Class II — Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
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FDA Device Recall: Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Fle
2021-03-10
Class II — System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
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FDA Device Recall: ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 w
2021-03-03
Class II — Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error...
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FDA Device Recall: SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confide
2021-01-20
Class II — System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
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FDA Device Recall: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
2021-01-20
Class II — When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can...
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FDA Device Recall: Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoro
2021-01-20
Class II — After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely ove...
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FDA Device Recall: Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fl
2021-01-20
Class II — After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely ove...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20201014
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. | Product: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20200909
This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific | Product: Symbia S-Series and Symbia T-Series - ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20200902
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an i | Product: Cios Spin, Image-Intensified Fluorosco...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20200520
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the syst | Product: Siemens Cios Alpha VA30-mobile X-Ray s...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20200415
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. | Product: MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRO...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20200325
A software issue could potentially cause the stand and table movements to be blocked. | Product: Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor,
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20200122
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator | Product: Siemens ARTIS pheno, Model # 10849000....
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FDA Device Recall: ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended U
2020-11-11
Class II — There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been st...
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FDA Device Recall: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
2020-10-14
Class II — Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
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FDA Device Recall: Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the devic
2020-09-09
Class II — This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential...
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FDA Device Recall: Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-
2020-09-09
Class II — The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignme...
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FDA Device Recall: Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cio
2020-09-02
Class II — Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
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FDA Device Recall: E.cam or Symbia systems that use foresight detectors - Product Usage: To detect
2020-09-02
Class II — E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurr...
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FDA Device Recall: Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios S
2020-09-02
Class II — Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and...
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FDA Device Recall: Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Ci
2020-09-02
Class II — Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
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FDA Device Recall: SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a d
2020-08-12
Class II — Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the...
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FDA Device Recall: SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model:
2020-08-12
Class II — Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the...
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FDA Device Recall: SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a d
2020-08-12
Class II — Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the...
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FDA Device Recall: MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used
2020-06-24
Class II — If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg...
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FDA Device Recall: Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray
2020-06-17
Class II — Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, a...
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FDA Device Recall: ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone
2020-06-10
Class II — Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and i...
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FDA Device Recall: Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103081
2020-06-03
Class II — The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrica...
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FDA Device Recall: Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alph
2020-05-20
Class II — Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 1630...
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FDA Device Recall: Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha
2020-05-20
Class II — Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 1630...
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FDA Device Recall: System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat pa
2020-05-13
Class II — It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be releas...
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FDA Device Recall: MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVAT
2020-04-15
Class II — Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
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FDA Device Recall: ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585792
2020-04-15
Class II — Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
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FDA Device Recall: Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354
2020-03-25
Class II — A software issue could potentially cause the stand and table movements to be blocked.
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FDA Device Recall: Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis
2020-03-25
Class II — A software issue could potentially cause the stand and table movements to be blocked.
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FDA Device Recall: Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray sys
2020-03-25
Class II — The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by usin...
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FDA Device Recall: Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic sys
2020-02-26
Class II — A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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FDA Device Recall: Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System
2020-01-22
Class II — The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190904
The injector holder could potentially fall off together with the injector and the storage box. | Product: SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is inten...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190731
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube wi | Product: AXIOM Artis dTC, Model Number 7413078
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190731
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube wi | Product: AXIOM Artis FA, Model Number 5904441
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190731
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube wi | Product: Artis zee floor MN, Model Number 10094...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190710
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay | Product: SOMATOM go.Up (Model #11061610) with s...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190710
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic del | Product: SOMATOM go.Now, Model No. 11061618 ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20190508
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Sie | Product: SOMATOM Definition AS with Option syng...
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FDA Device Recall: Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 1009414
2019-12-25
Class II — In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a de...
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FDA Device Recall: SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
2019-11-27
Class II — SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence du...
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FDA Device Recall: Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Sca
2019-11-20
Class II — Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
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FDA Device Recall: Mammomat Revelation with software version VC10 and Biopsy Option Intended Use
2019-10-30
Class II — An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
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FDA Device Recall: syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomograp
2019-09-11
Class II — SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected...
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FDA Device Recall: SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography s
2019-09-04
Class II — The injector holder could potentially fall off together with the injector and the storage box.
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FDA Device Recall: SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography s
2019-09-04
Class II — The injector holder could potentially fall off together with the injector and the storage box.
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FDA Device Recall: SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed t
2019-09-04
Class II — The injector holder could potentially fall off together with the injector and the storage box.
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FDA Device Recall: SOMATOM go.All; Models #11061638 Product Usage: This computed tomography s
2019-09-04
Class II — The injector holder could potentially fall off together with the injector and the storage box.
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FDA Device Recall: ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemen
2019-08-28
Class II — The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values ba...
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FDA Device Recall: MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
2019-08-28
Class II — Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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FDA Device Recall: ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Med
2019-08-28
Class II — The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values ba...
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FDA Device Recall: MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
2019-08-28
Class II — Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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FDA Device Recall: ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Sieme
2019-08-28
Class II — The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values ba...
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FDA Device Recall: ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medi
2019-08-28
Class II — The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values ba...
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FDA Device Recall: MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
2019-08-28
Class II — Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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FDA Device Recall: MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
2019-08-28
Class II — Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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FDA Device Recall: SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography system
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography system
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography sy
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomogra
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomogr
2019-08-21
Class II — Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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FDA Device Recall: Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to a
2019-08-14
Class II — Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
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FDA Device Recall: Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to
2019-08-14
Class II — Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
View Source
FDA Device Recall: AXIOM Artis dTC, Model Number 7413078
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
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FDA Device Recall: AXIOM Artis FA, Model Number 5904441
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: Artis zee floor MN, Model Number 10094142
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis dMP, Model Number 7555365
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
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FDA Device Recall: AXIOM Artis dBC, Model Number 7728392
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: Artis zee ceiling, Model Number 10094137
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis dBA, Model Number 7555357
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis dFA, Model Number 7555373
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: Artis zee floor, Model Number 10094135
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis dTA, Model Number 7008605
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: Artis zee biplane, Model Number 10094141
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
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FDA Device Recall: Artis zeego, Model Number 10280959
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: Artis zee multi, Model Number 10094139
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis TA, Model Number 7007755
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis dFC, Model Number 7727717
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
View Source
FDA Device Recall: AXIOM Artis BA, Model Number 5904656
2019-07-31
Class II — A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required vo...
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FDA Device Recall: Cios care fusion system
2019-07-17
Class II — DAP chamber may be missing an insulating foil
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FDA Device Recall: Cios Alpha VA20/ VA30 mobile X-Ray systems
2019-07-17
Class II — DAP chamber may be missing an insulating foil
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FDA Device Recall: SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0
2019-07-10
Class II — The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
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FDA Device Recall: SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA
2019-07-10
Class II — The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
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FDA Device Recall: Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number:
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA
2019-07-10
Class II — The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
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FDA Device Recall: Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
View Source
FDA Device Recall: Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number:
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number:
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_S
2019-07-10
Class II — The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
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FDA Device Recall: Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP
2019-07-10
Class II — The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
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FDA Device Recall: Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Numbe
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
View Source
FDA Device Recall: Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Numb
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_S
2019-07-10
Class II — The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
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FDA Device Recall: Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number
2019-07-10
Class II — Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot be...
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FDA Device Recall: Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is
2019-05-22
Class II — In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
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FDA Device Recall: Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee
2019-05-22
Class II — In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
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FDA Device Recall: Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee
2019-05-22
Class II — In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
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FDA Device Recall: Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200
2019-05-15
Class II — Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-r...
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FDA Device Recall: SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral D
2019-05-08
Class II — Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a si...
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FDA Device Recall: SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography
2019-05-08
Class II — Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a si...
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FDA Device Recall: SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomog
2019-05-08
Class II — Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a si...
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FDA Device Recall: Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Pri
2019-05-01
Class II — Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collisio...
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FDA Device Recall: Sensis Vibe System, Model Number 11007642, with software version VD10B.
2019-03-06
Class II — A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different syste...
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FDA Device Recall: Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph
2019-01-16
Class II — Improper design or specifications.
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20181121
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support | Product: ARTIS Q biplane with Material 10848282- - a An...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180704
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is stil | Product: Artis Q.zen floor, Material no. 108483...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180704
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is stil | Product: Artis Q.zeego, Material no. 10848283, ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180509
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or | Product: SOMATOM Spirit Intended to produce ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180509
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or | Product: SOMATOM Sensation Open Intended to ...
View Source
FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180509
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or | Product: SOMATOM Scope Intended to produce c...
View Source
FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180425
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements | Product: PRIMUS HI, Digital Linear Accelerator,...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180307
Potential for liquid entry | Product: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807,
View Source
FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180307
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain | Product: Artis Q and Q.zen model Interventional...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20180207
Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) | Product: Syngo.plaza Picture Archiving and Comm...
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FDA Device Recall: ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Produc
2018-11-21
Class II — Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
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FDA Device Recall: ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Pro
2018-11-21
Class II — Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
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FDA Device Recall: ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system
2018-11-21
Class II — Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
View Source
FDA Device Recall: Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7
2018-11-07
Class II — In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock...
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FDA Device Recall: EVO Excel, Emission Computed Tomographic System, Material Number 10910501
2018-11-07
Class II — The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
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FDA Device Recall: Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042
2018-11-07
Class II — In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock...
View Source
FDA Device Recall: Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Nu
2018-10-24
Class II — The terminals on the plug may become loose and overheat.
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FDA Device Recall: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
2018-09-26
Class II — Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur whil...
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FDA Device Recall: 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling st
2018-08-29
Class II — In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock ...
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FDA Device Recall: 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Us
2018-08-29
Class II — In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock ...
View Source
FDA Device Recall: ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product
2018-08-22
Class II — Potential hardware issue which may cause thermal effects and possible damage to system parts.
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FDA Device Recall: SOMATOM Emotion 6 (Model 10165888)
2018-08-08
Class II — A potential risk of unnecessary radiation exposure due to a software issue
View Source
FDA Device Recall: SOMATOM Perspective 16 (Model 10891666)
2018-08-08
Class II — A potential risk of unnecessary radiation exposure due to a software issue
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FDA Device Recall: SOMATOM Perspective (Model 10495568)
2018-08-08
Class II — A potential risk of unnecessary radiation exposure due to a software issue
View Source
FDA Device Recall: SOMATOM Scope Power (Model 10967888)
2018-08-08
Class II — A potential risk of unnecessary radiation exposure due to a software issue
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FDA Device Recall: SOMATOM Spirit(Model 10045692 )
2018-08-08
Class II — A potential risk of unnecessary radiation exposure due to a software issue
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FDA Device Recall: ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
2018-08-01
Class II — During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system contr...
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FDA Device Recall: AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an
2018-08-01
Class II — Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoin...
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FDA Device Recall: Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiogr
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographi
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: Artis Q biplane, Material no. 10848282, for angiography and whole body radiograp
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: Artis Q ceiling, Material no. 10848281, for angiography and whole body radiograp
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
2018-07-04
Class II — If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and...
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FDA Device Recall: Artis zee biplane MN, Material no. 10094143, for angiography and whole body radi
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: Artis zeego, Material no. 10280959 , for angiography and whole body radiographi
2018-07-04
Class II — After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur ...
View Source
FDA Device Recall: SOMATOM Go.Up, Material Number 11061628 There is a potential for a software i
2018-06-06
Class II — There is a potential for a software issue that may cause the need for necessary patient rescans.
View Source
FDA Device Recall: SOMATOM go.Now, Material Number 11061618 There is a potential for a software
2018-06-06
Class II — There is a potential for a software issue that may cause the need for necessary patient rescans.
View Source
FDA Device Recall: Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide
2018-05-30
Class II — Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware cha...
View Source
FDA Device Recall: SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic syste
2018-05-23
Class II — There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Defin...
View Source
FDA Device Recall: SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic s
2018-05-23
Class II — There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Defin...
View Source
FDA Device Recall: SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic s
2018-05-23
Class II — There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Defin...
View Source
FDA Device Recall: Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.
2018-05-16
Class II — Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
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FDA Device Recall: Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication
2018-05-16
Class II — Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
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FDA Device Recall: Syngo.Via VB20A model 1049610
2018-05-16
Class II — Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor p...
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FDA Device Recall: SOMATOM Spirit Intended to produce cross-sections images of the body by compu
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Sensation Open Intended to produce cross-sections images of the body
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Scope Intended to produce cross-sections images of the body by comput
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Sensation 64 Intended to produce cross-sections images of the body by
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Emotion (2003) Intended to produce cross-sections images of the body
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Perspective Intended to produce cross-sections images of the body by
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagn
2018-05-09
Class II — Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, in...
View Source
FDA Device Recall: SOMATOM Sensation 40 Intended to produce cross-sections images of the body by
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: SOMATOM Sensation Cardiac Intended to produce cross-sections images of the bo
2018-05-09
Class II — to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. De...
View Source
FDA Device Recall: PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The
2018-04-25
Class II — Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment tab...
View Source
FDA Device Recall: MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035
2018-04-25
Class II — Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment tab...
View Source
FDA Device Recall: ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usa
2018-04-25
Class II — Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment tab...
View Source
FDA Device Recall: Syngo.via software is intended to be used for viewing, manipulation, communicati
2018-04-04
Class II — When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up tempor...
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FDA Device Recall: Artis one fluoroscopic x-ray system and patient table Artis one is an angio
2018-03-28
Class II — Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
View Source
FDA Device Recall: AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392
2018-03-28
Class II — Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or r...
View Source
FDA Device Recall: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755
2018-03-07
Class II — Potential for liquid entry
View Source
FDA Device Recall: Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot s
2018-03-07
Class II — The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it...
View Source
FDA Device Recall: SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 1106162
2018-03-07
Class II — The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
View Source
FDA Device Recall: Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch
2018-03-07
Class II — The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it...
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FDA Device Recall: AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of
2018-02-14
Class II — Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to qua...
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FDA Device Recall: Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173
2018-02-14
Class II — When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow St...
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FDA Device Recall: Syngo.plaza Picture Archiving and Communication System (PACS) with software vers
2018-02-07
Class II — Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorize...
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FDA Device Recall: Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communic
2018-01-31
Class II — Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20171101
The torque wrench used to tighten system bolts during installation was found to be out of tolerance | Product: Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel mod...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20170906
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failur | Product: Artis zee/zeego and Artis Q/Q.zen syst...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20170118
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | Product: Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The ...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20170118
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | Product: Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 Th...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20170118
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | Product: Biograph mCT S(40)-4R, Material Number 10248671 The Siemens...
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FDA Device Recall: Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171
2017-11-29
Class II — Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom ...
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FDA Device Recall: Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detec
2017-11-22
Class II — The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantifi...
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FDA Device Recall: Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect
2017-11-22
Class II — The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantifi...
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FDA Device Recall: Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo
2017-11-01
Class II — The torque wrench used to tighten system bolts during installation was found to be out of tolerance
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee
2017-09-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This ...
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FDA Device Recall: Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 109106
2017-07-12
Class II — Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the ...
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FDA Device Recall: AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a di
2017-05-31
Class II — An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can...
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FDA Device Recall: 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versi
2017-05-03
Class II — When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple ima...
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FDA Device Recall: Artis zee, Angiographic x-ray system
2017-04-26
Class II — Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly ...
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FDA Device Recall: Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra
2017-04-19
Class II — Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.
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FDA Device Recall: Syngo.x, Picture archiving and communication system Syngo via is a software sol
2017-04-05
Class II — Software changes now available to address several issues
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FDA Device Recall: ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
2017-03-29
Class II — Software update
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FDA Device Recall: ARTIS Q, Interventional Fluroscopic x-ray system
2017-03-29
Class II — In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
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FDA Device Recall: Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is
2017-03-29
Class II — Software updates
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FDA Device Recall: Mevatron M2/Primus Mid-Energy PRIMUS HI
2017-03-29
Class II — Software update
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FDA Device Recall: Artis Q and Q.Zen fluoroscopic x-ray system
2017-03-22
Class II — A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids....
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FDA Device Recall: PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The i
2017-03-15
Class II — Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This c...
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FDA Device Recall: Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/
2017-03-15
Class II — The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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FDA Device Recall: MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the
2017-03-15
Class II — Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This c...
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FDA Device Recall: MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the
2017-03-15
Class II — Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This c...
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FDA Device Recall: MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The
2017-03-15
Class II — Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This c...
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FDA Device Recall: Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs ar
2017-03-15
Class II — The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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FDA Device Recall: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobil
2017-03-15
Class II — The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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FDA Device Recall: ONCOR Avant-garde, medical charged-particle radiation therapy system Product
2017-02-22
Class II — Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the o...
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FDA Device Recall: ARTISTE MV System, medical charged-particle radiation therapy system Product
2017-02-22
Class II — Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the o...
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FDA Device Recall: PRIMUS Medical charged-particle radiation therapy system Product Usage: The
2017-02-22
Class II — Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the o...
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FDA Device Recall: ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-pa
2017-02-22
Class II — Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the o...
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FDA Device Recall: Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Us
2017-02-08
Class II — Software error
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FDA Device Recall: Syngo.plaza, picture archiving and communications system.
2017-02-08
Class II — Software update for improvements and to resolve several issues
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FDA Device Recall: Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mC
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and B
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and B
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and B
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biogr
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and B
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and B
2017-01-18
Class II — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
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FDA Device Recall: SOMATOM Perspective, Computed tomography x-ray system
2017-01-04
Class II — Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of ...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20161207
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal trans | Product: Z6Ms transesophageal transducers used ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20161123
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definit | Product: SOMATOM Definition Flash, Computed tom...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20161123
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definit | Product: SOMATOM Definition Edge, Computed tomo...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20161123
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definitio | Product: SOMATOM Definition Flash, Computed tom...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20161012
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal p | Product: Multix Fusion Stationary X-Ray System ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20160817
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump sys | Product: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHI...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20160706
Software error in previous software versions in which two references for the same image may exist in the database. | Product: Syngo.plaza, Picture archiving and communication system (PACS), Model Numb...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20160629
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibratio | Product: BIOGRAPH mCT Flow 20-4R, MATERIAL NUMB...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20160629
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibratio | Product: SYS IVK, Bio mCT-S(40) 3R->4R Upgrade,...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20160629
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibratio | Product: BIOGRAPH 40 TruePoint w/TrueV, Materia...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20160629
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibratio | Product: Biograph mCT-S(64) 3R, MATERIAL NUMBER...
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FDA Recall: Siemens Medical Solutions USA Inc. — Class II
20160629
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibratio | Product: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMB...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20160406
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA invest | Product: The Symbia gamma camera system Pro...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20160406
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion o | Product: Siemens branded SOMATOM Emotion and SO...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20160406
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA invest | Product: The E.CAM gamma camera system Prod...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20160302
Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not | Product: Syngo Plaza Picture archiving and comm...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20160302
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix da | Product: software for Syngo Dynamics a Pict...
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FDA Device Recall: SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce
2016-12-21
Class II — Software update that provides software and firmware bug-fixes to improve system performance
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FDA Device Recall: SOMATOM Force, System x-ray, tomography, computed
2016-12-14
Class II — Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Corre...
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FDA Device Recall: Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms
2016-12-07
Class II — Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
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FDA Device Recall: SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM
2016-11-23
Class II — Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Syst...
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FDA Device Recall: SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM D
2016-11-23
Class II — Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Syst...
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FDA Device Recall: SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM
2016-11-23
Class II — A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by e...
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FDA Device Recall: SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Def
2016-11-23
Class II — A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by e...
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FDA Device Recall: Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a fa
2016-11-23
Class II — The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
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FDA Device Recall: SOMATOM Definition AS system, x-ray, tomography, computed
2016-11-16
Class II — Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
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FDA Device Recall: Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radi
2016-10-19
Class II — The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to...
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FDA Device Recall: Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion syste
2016-10-12
Class II — Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the...
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FDA Device Recall: Syngo.plaza, Picture Archiving and Communication System
2016-10-05
Class II — Software upgrade to eliminate several issues
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FDA Device Recall: Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a softwa
2016-10-05
Class II — Software patch installation to address several safety issues.
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FDA Device Recall: PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator
2016-10-05
Class II — Software patch installation to address several safety issues.
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FDA Device Recall: ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded A
2016-10-05
Class II — Software patch installation to address several safety issues.
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FDA Device Recall: Syngo.x picture archiving and communication system Syngo.x is a software solu
2016-09-28
Class II — Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too...
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FDA Device Recall: Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process
2016-09-21
Class II — Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on proj...
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FDA Device Recall: e.cam and Symbia E gamma camera systems with patient beds To detect or image
2016-09-14
Class II — "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instru...
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FDA Device Recall: SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, compu
2016-08-31
Class II — Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contra...
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FDA Device Recall: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-r
2016-08-17
Class II — The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
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FDA Device Recall: ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego
2016-08-17
Class II — The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
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FDA Device Recall: AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis
2016-08-17
Class II — The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
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FDA Device Recall: Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model
2016-08-17
Class II — Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
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FDA Device Recall: Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers -
2016-07-06
Class II — Software error in previous software versions in which two references for the same image may exist in the database.
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FDA Device Recall: BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePo
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens B
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph Tr
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoin
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePo
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePo
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograp
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograp
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoin
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePo
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph Tr
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TrueP
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoin
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biogr
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint sy
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Bio
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biogra
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoin
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph True
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoin
2016-06-29
Class II — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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FDA Device Recall: Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens B
2016-06-22
Class II — The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
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FDA Device Recall: BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens
2016-06-22
Class II — The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
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FDA Device Recall: BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens
2016-06-22
Class II — The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
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FDA Device Recall: BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens
2016-06-22
Class II — The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
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FDA Device Recall: MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Mode
2016-05-11
Class II — The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet...
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FDA Device Recall: ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 106
2016-05-04
Class II — Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes ...
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FDA Device Recall: Siemens SOMATOM Definition: Intended to produce cross-sectional images of the bo
2016-04-27
Class II — Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the n...
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FDA Device Recall: Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and
2016-04-27
Class II — Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the ne...
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FDA Device Recall: The Symbia gamma camera system Product Usage: The Symbia gamma camera syste
2016-04-06
Class II — We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e....
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FDA Device Recall: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems int
2016-04-06
Class II — Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunct...
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FDA Device Recall: The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system
2016-04-06
Class II — We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e....
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FDA Device Recall: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems int
2016-04-06
Class II — Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunct...
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FDA Device Recall: AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Arti
2016-04-06
Class II — Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This l...
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FDA Device Recall: Cios Alpha, mobile X-ray system
2016-04-06
Class II — Software issues on Cios Alpha mobile C-Arm system
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FDA Device Recall: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems int
2016-04-06
Class II — Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunct...
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FDA Device Recall: Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic
2016-04-06
Class II — Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
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FDA Device Recall: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems int
2016-04-06
Class II — Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunct...
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FDA Device Recall: AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imag
2016-04-06
Class II — Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
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FDA Device Recall: CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The C
2016-04-06
Class II — Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The...
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FDA Device Recall: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems int
2016-04-06
Class II — Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunct...
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FDA Device Recall: syngo X Workplace is a medical workstation for real-time viewing, image manipula
2016-03-30
Class II — After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
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FDA Device Recall: Syngo Plaza Picture archiving and communication system. Software only. PACS in
2016-03-02
Class II — Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; chang...
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FDA Device Recall: software for Syngo Dynamics a Picture Archiving and Communication System (PA
2016-03-02
Class II — Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
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FDA Device Recall: Mammomat Inspiration with Tomosynthesis functionality
2016-03-02
Class II — A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. ...
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FDA Device Recall: The e.cam Dual Signature Gamma Camera system. Used to detect or image the distr
2016-01-27
Class II — To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20151202
To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for al | Product: Syngo Imaging VB36D_HF02. Radiologica...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20151014
Software and firmware bugs | Product: SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20150708
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as pa | Product: ACUSON SC2000 Ultrasound Systems betwe...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20150603
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable det | Product: SIEMENS Ysio Max; a radiographic syst...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20150318
Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system st | Product: SIEMENS SOMATOM Force with software ve...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20150121
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components. | Product: Symbia T and Symbia T2 computer tomography systems. These systems are u...
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FDA Recall: Siemens Medical Solutions USA, Inc. — Class II
20150114
There is a potential for patient finger injury on the e.cam systems. | Product: e.cam -emission computed tomography system Used to detect or image the distribution of radionucli
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FDA Device Recall: Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
2015-12-30
Class II — For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjuncti...
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FDA Device Recall: Artis systems with large display from Siemens Medical Solutions USA, Inc. Inter
2015-12-30
Class II — Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been obser...
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FDA Device Recall: Syngo Imaging VB36D_HF02. Radiological image processing system.
2015-12-02
Class II — To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running o...
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FDA Device Recall: MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
2015-11-18
Class II — Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
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FDA Device Recall: e.cam Gamma Camera, an emission computed tomography system. It is intended to de
2015-11-11
Class II — Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will fo...
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FDA Device Recall: ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PR
2015-11-04
Class II — potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Seq...
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FDA Device Recall: SOMATOM Force; computed tomography x-ray system. Intended to generate and pro
2015-10-14
Class II — Software and firmware bugs
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FDA Device Recall: SOMATOM Definition Edge; intended to produce cross-sectional images of the body
2015-10-14
Class II — software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction ...
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FDA Device Recall: SOMATOM Definition AS, intended to produce cross-sectional images of the body by
2015-10-14
Class II — software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction ...
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FDA Device Recall: ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIM
2015-09-30
Class II — A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
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FDA Device Recall: ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 1
2015-09-23
Class II — The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these ...
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FDA Device Recall: Syngo.plaza; picture archiving and communications system Product Usage: Syng
2015-09-09
Class II — Potential issue leading to data loss and patient data mix-up
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FDA Device Recall: Artis zee/ zeego systems; dedicated angiography systems developed for single and
2015-08-26
Class II — in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to eithe...
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FDA Device Recall: Siemens Symbia S Series system, a diagnostic analog or digital detector based pl
2015-08-26
Class II — Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Cont...
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FDA Device Recall: Siemens Intevo Series system, a radiological imaging system that is a combinatio
2015-08-26
Class II — Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Cont...
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FDA Device Recall: Siemens Artis zee systems; dedicated angiography systems developed for single a
2015-08-12
Class II — The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer b...
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FDA Device Recall: Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: Artis Q systems; dedicated angiography systems developed for single and biplane
2015-08-12
Class II — The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer b...
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FDA Device Recall: Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: Biograph mCT S(64)-4R, Model Number 10248672
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: Biograph mCT S(40)-4R, Model Number 10248671
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
2015-08-12
Class II — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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FDA Device Recall: ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software
2015-08-05
Class II — Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
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FDA Device Recall: ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ optio
2015-08-05
Class II — Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of th...
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FDA Device Recall: ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and w
2015-07-08
Class II — When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
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FDA Device Recall: SOMATOM Emotion 16; produce cross-sectional images of the body by computer recon
2015-07-08
Class II — A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer...
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FDA Device Recall: SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Co
2015-07-08
Class II — During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
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FDA Device Recall: SOMATOM Emotion 6; produce cross-sectional images of the body by computer recons
2015-07-08
Class II — A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer...
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FDA Device Recall: syngo Workflow SLR; The information system syngo Workflow SLR is a digital radio
2015-06-10
Class II — A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature,...
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FDA Device Recall: SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical
2015-06-03
Class II — Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic...
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FDA Device Recall: SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-s
2015-06-03
Class II — Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow...
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FDA Device Recall: SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluor
2015-06-03
Class II — Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic...
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FDA Device Recall: SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-
2015-06-03
Class II — Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow...
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FDA Device Recall: SOMATOM Perspective; the intended use of computed tomography is to produce cross
2015-06-03
Class II — Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow...
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FDA Device Recall: AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray sy
2015-05-13
Class II — If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
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FDA Device Recall: ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model num
2015-05-13
Class II — In certain situations, loss of post exercise images can occur in Stress Echo.
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FDA Device Recall: Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to di
2015-04-08
Class II — Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet b...
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FDA Device Recall: MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicate
2015-04-01
Class II — The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occ...
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FDA Device Recall: Siemens LANTIS Oncology Information System Servers; allows the radiation therap
2015-03-25
Class II — There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the pa...
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FDA Device Recall: E.CAM emission computed tomography system used to detect or image the distributi
2015-03-25
Class II — Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
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FDA Device Recall: ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The in
2015-03-25
Class II — There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
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FDA Device Recall: Symbia E is a multi-purpose SPECT system used to detect or image the distributio
2015-03-25
Class II — Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
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FDA Device Recall: SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A
2015-03-18
Class II — Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handl...
View Source
FDA Device Recall: Artis One; The Artis One is an angiography system developed for diagnostic inter
2015-02-25
Class II — The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
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FDA Device Recall: ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The
2015-02-18
Class II — There is a low probability the scanner arm will become completely detached from the scanner column.
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FDA Device Recall: ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2.
2015-02-11
Class II — The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
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FDA Device Recall: Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and
2015-02-04
Class II — Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset ca...
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FDA Device Recall: Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and S
2015-01-28
Class II — Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotat...
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FDA Device Recall: Symbia T and Symbia T2 computer tomography systems. These systems are used to pe
2015-01-21
Class II — There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
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FDA Device Recall: SOMATOM Force; the intended use of computed tomography is to produce cross-secti
2015-01-21
Class II — Artifacts are found in acquired imaging on the SOMATOM Force.
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FDA Device Recall: Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The
2015-01-21
Class II — Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a sy...
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FDA Device Recall: Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141
2015-01-21
Class II — The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without a...
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FDA Device Recall: e.cam -emission computed tomography system Used to detect or image the distri
2015-01-14
Class II — There is a potential for patient finger injury on the e.cam systems.
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FDA Device Recall: The Siemens Symbia S series is intended for use by appropriately trained health
2015-01-14
Class II — Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related inj...
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FDA Device Recall: The Siemens Symbia T series is intended for use by appropriately trained health
2015-01-14
Class II — Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related inj...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20141217
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not | Product: Syngo.plaza, Syngo.plaza VB10A, and sy...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20141210
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated aga | Product: The Artis zee / zeego Angiography Syst...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20141008
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile | Product: Siemens AXIOM Luminos dRF Max systems...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20141001
There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Displa | Product: Artis zee and Artis zeego systems. ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140730
Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur f | Product: Siemens syngo Imaging XS, version VA70...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140604
Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which | Product: Siemens Linear Accelerator (LINAC) mod...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140604
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manu | Product: MAGNETOM Aera magnetic resonance syste...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140409
An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted mane | Product: Artis Zee Angiographic x-ray systems.
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140402
Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system | Product: AXIOM Artis Systems Product usage: ...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20140305
During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage | Product: Siemens Artis zee Ceiling Systems. ...
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FDA Device Recall: Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT
2014-12-24
Class II — Possibility for system display freeze during CT interventional procedures.
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FDA Device Recall: Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph
2014-12-24
Class II — Possibility for system display freeze during CT interventional procedures.
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FDA Device Recall: Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biogr
2014-12-24
Class II — Possibility for system display freeze during CT interventional procedures.
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FDA Device Recall: Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syn
2014-12-17
Class II — Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. T...
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FDA Device Recall: The Artis zee / zeego Angiography System is designed as a set of components that
2014-12-10
Class II — There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiatio...
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FDA Device Recall: Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration s
2014-10-29
Class II — The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety s...
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FDA Device Recall: e.cam line of gamma camera systems Used to detect or image the distribution
2014-10-29
Class II — Reports of loose bolts in the detector support structure of Symbia and e.cam systems.
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FDA Device Recall: Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient cent
2014-10-29
Class II — Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
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FDA Device Recall: Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be
2014-10-08
Class II — Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of seri...
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FDA Device Recall: Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a
2014-10-08
Class II — Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of seri...
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FDA Device Recall: Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector f
2014-10-08
Class II — Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of seri...
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FDA Device Recall: Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals
2014-10-08
Class II — Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of seri...
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FDA Device Recall: Artis zee and Artis zeego systems. x-ray, angiographic system
2014-10-01
Class II — There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances,...
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FDA Device Recall: The Ysio Systems with software version VC10 The Ysio enables radiographic and
2014-10-01
Class II — Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appea...
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FDA Device Recall: AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Lumino
2014-09-24
Class II — It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate ...
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FDA Device Recall: Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is
2014-09-17
Class II — It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlike...
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FDA Device Recall: V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE
2014-09-10
Class II — Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
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FDA Device Recall: Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Pictu
2014-07-30
Class II — Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functio...
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FDA Device Recall: e.cam camera system. Emission Computed Tomography System used to detect or imag
2014-07-23
Class II — Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
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FDA Device Recall: Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett
2014-07-09
Class II — There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens M...
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FDA Device Recall: ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B;
2014-07-09
Class II — There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
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FDA Device Recall: Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANT
2014-07-02
Class II — There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as...
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FDA Device Recall: Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with softwa
2014-07-02
Class II — When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of t...
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FDA Device Recall: Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are r
2014-06-11
Class II — Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
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FDA Device Recall: Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray rad
2014-06-04
Class II — Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compat...
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FDA Device Recall: MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic reso
2014-06-04
Class II — Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
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FDA Device Recall: Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS)
2014-05-21
Class II — Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
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FDA Device Recall: MULTIX FUSION. The Multix Fusion system is a radiographic system used in hosp
2014-04-30
Class II — It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be ...
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FDA Device Recall: AXIOM Vertix MD Trauma systems radiographic X-ray
2014-04-23
Class II — There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective wi...
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FDA Device Recall: Artis Zee Angiographic x-ray systems.
2014-04-09
Class II — An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
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FDA Device Recall: AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiog
2014-04-02
Class II — Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the g...
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FDA Device Recall: Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional
2014-04-02
Class II — There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat dete...
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FDA Device Recall: syngo Dynamics Picture Archiving and Communication System (PACS). Model number
2014-03-26
Class II — Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for...
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FDA Device Recall: Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
2014-03-05
Class II — During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
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FDA Device Recall: Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edg
2014-02-12
Class II — During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B ...
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FDA Device Recall: ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Sol
2014-02-05
Class II — The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or contro...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130904
Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, t | Product: PRIMUS, ONCOR, ARTISTE Linac systems w...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130410
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The softw | Product: SIEMENS brand COHERENCE RT Therapist v...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130410
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The softw | Product: SIEMENS brand COHERENCE RT Therapist v...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130410
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The softw | Product: SIEMENS brand COHERENCE RT Therapist v...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130403
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under ce | Product: Artis Systems with Software Artis VC20...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130320
Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality. | Product: Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo C...
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FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20130313
Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT | Product: SIEMENS brand ARTISTE syngo RT Therapi...
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FDA Device Recall: SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photo
2013-12-11
Class II — A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat...
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FDA Device Recall: SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any
2013-12-11
Class II — A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat...
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FDA Device Recall: (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop O
2013-12-04
Class II — A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation co...
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FDA Device Recall: Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg
2013-10-30
Class II — Software issue results in inaccurate 3D image may result in ablation in wrong location.
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FDA Device Recall: PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1
2013-09-04
Class II — Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in pos...
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FDA Device Recall: Siemens AXIOM Artis zeego x-ray, angiographic system
2013-08-21
Class II — Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
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FDA Device Recall: Siemens syngo.plaza SW version VA20 with Mammography license. image processi
2013-08-21
Class II — Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography im...
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FDA Device Recall: Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
2013-08-07
Class II — Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into...
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FDA Device Recall: syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ D
2013-08-07
Class II — Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end...
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FDA Device Recall: Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. Th
2013-07-31
Class II — Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lyin...
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FDA Device Recall: Siemens Mammomat Inspiration - full-field digital mammography Product Usage:
2013-07-17
Class II — Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch w...
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FDA Device Recall: Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST
2013-07-10
Class II — The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this is...
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FDA Device Recall: ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use
2013-06-26
Class II — The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that wer...
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FDA Device Recall: Software correction applies to customers who use the RT Therapist RTT4.2.108 an
2013-05-08
Class II — Software update to fix multiple safety related issues.
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FDA Device Recall: Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/S
2013-04-24
Class II — Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patie...
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FDA Device Recall: Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that con
2013-04-17
Class II — When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hard...
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FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
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FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
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FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
View Source
FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
View Source
FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
View Source
FDA Device Recall: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.
2013-04-10
Class II — Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final sy...
View Source
FDA Device Recall: Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license inst
2013-04-03
Class II — The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap ...
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FDA Device Recall: Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo
2013-03-20
Class II — Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
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FDA Device Recall: ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Di
2013-03-20
Class II — On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
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FDA Device Recall: SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part
2013-03-13
Class II — Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously complete...
View Source
FDA Recall: Siemens Medical Solutions USA, Inc — Class II
20120801
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it c | Product: Siemens syngo.plaza. Radiological ...
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FDA Device Recall: MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceili
2012-12-19
Class II — A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
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FDA Device Recall: Siemens Mobilette Mira, intended use as Mobile x-ray system.
2012-12-12
Class II — There is a risk of lost images during examination.
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FDA Device Recall: Siemens syngo.plaza Radiological Image Processing System Usage: Radiological
2012-12-12
Class II — Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the foll...
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FDA Device Recall: Siemens syngo.plaza radiological image processing system.
2012-10-17
Class II — Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, ...
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FDA Device Recall: Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Reso
2012-10-03
Class II — When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center positio...
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FDA Device Recall: Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
2012-09-19
Class II — Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Ac...
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FDA Device Recall: Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray syst
2012-09-19
Class II — During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal c...
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FDA Device Recall: Siemens syngo.plaza. Radiological image processing system
2012-08-01
Class II — Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not load...
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lobbying
5 records
Lobbying Firm: SIEMENS MEDICAL SOLUTIONS USA, INC
Registered lobbying firm — Washington, DC — Healthcare diagnostics
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Lobbying Client: SIEMENS MEDICAL SOLUTIONS USA, INC.
Lobbied by BRICK STREET STRATEGY — Manufacturer of medical devices, technology and software.
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Lobbying Client: SIEMENS MEDICAL SOLUTIONS USA, INC.
Lobbied by AVENUE SOLUTIONS — Healthcare diagnostics
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Lobbying Client: SIEMENS MEDICAL SOLUTIONS USA, INC.
Lobbied by AVENUE SOLUTIONS — Healthcare diagnostics
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Lobbying Client: SIEMENS MEDICAL SOLUTIONS USA, INC.
Lobbied by AVENUE SOLUTIONS — Healthcare diagnostics
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ny_corps
1 records
NY Corp: SIEMENS MEDICAL SOLUTIONS USA, INC.
1984-10-11
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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USASpending
18 records
Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $3,296,646
2026-05-08
MODALITY: XR-MRI REQUISITION: 558B69006 STATION: DURHAM VA MEDICAL CENTER REQUIREMENT: URGENT MRI REPLACEMENT
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,957,970
2026-05-01
MODALITY: NM PET CT PURCHASE ORDER: 589B50014 STATION: VAMC KANSAS CITY, MO REQUIREMENT: SEPT FY25 EQ CONSOLIDATION
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,229,670
2026-04-21
MODALITY: XR CT PURCHASE ORDER: 636B50023 STATION: VAMC OMAHA NE REQUIREMENT: SEP FY25 EQ CONSOLIDATION
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,718,494
2026-04-09
MODALITY: XR CATH LAB STATION: VAMC COLUMBIA, SC PURCHASE ORDER: 36A79726F0096, 544B52002, 544B52010 REQUIREMENT: ADMINISTRATIVE CORRECTIONS
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $2,941,577
2026-03-31
MODALITY: XR MRI REQUISITION: 523B51025 STATION: VAMC WEST ROXBURY REQUIREMENT: MRI SYSTEMS
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,655,345
2026-01-30
NM SPECT CT 509B52002 TKY 509B52003 CHARLIE NORWOOD VA MEDICAL CENTER AUGUSTA, GA
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $3,061,897
2025-11-01
SIEMENS HCHT MODALITIES FULL-SERVICE
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $2,189,647
2025-03-17
XR RF, 618-B49000, MINNEAPOLIS, MN, CONSOLIDATION
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $3,506,819
2024-09-17
XR MRI, EQ 516-B40027, TKY 516-B40024, ST. PETERBURG, FL, CONSOLIDATION
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $3,857,000
2024-04-01
SIEMENS IMAGERY SYSTEMS SOFTWARE, PREVENTATIVE MAINTENANCE, AND REPAIR SERVICE AGREEMENT (BASE + 4 YEARS)
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,149,377
2024-04-01
HOSPITAL IMAGING CONTRACT
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $4,197,776
2024-02-01
SIEMENS PM - DETROIT
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $2,182,220
2022-11-15
SERVICE IMAGING EQUIPMENT FOR THE CLEMENT J. ZABLOCKI VA MEDICAL CENTER AND THE MILO C. HUEMPFNER, HEALTHCARE CENTER.
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,767,241
2022-11-04
X-RAY IMAGING SERVICES
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $3,100,452
2022-10-01
SIEMENS RAIDIOLOGY EQUIPMENT MAINTENANCE
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,327,404
2022-10-01
LOU VAMC IR AND CATH LAB SIEMENS EQUIPMENT PM
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Federal Award: SIEMENS MEDICAL SOLUTIONS USA, INC. — $1,085,321
2021-11-23
MAY FY21 CONSOLIDATION NM SPECT CT
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Federal Contractor: SIEMENS MEDICAL SOLUTIONS USA, INC.
Total awards: $194,171,682 | UEI: KFMJVLKNLZ75 | DUNS: 103231817
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