EPA (Environmental Protection Agency)
2 records
fda
470 records
FDA Recall: GE Healthcare LLC — Class II
20260408
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with fer | Product: SIGNA Premier systems
View Source
FDA Device Recall: SIGNA Premier systems
2026-04-08
Class II — Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-fe...
View Source
FDA Device Recall: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers:
2026-03-11
Class II — Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6...
View Source
FDA Recall: GE Healthcare — Class II
20250409
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & C | Product: GE Healthcare Centricity Centricity PA...
View Source
FDA Device Recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin
2025-12-24
Class II — GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
View Source
FDA Device Recall: GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers
2025-04-09
Class II — There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) wh...
View Source
FDA Device Recall: GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0
2025-04-09
Class II — There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) wh...
View Source
FDA Device Recall: GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;
2025-04-09
Class II — There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) wh...
View Source
FDA Device Recall: GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390
2025-04-09
Class II — There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) wh...
View Source
FDA Device Recall: GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2
2024-11-13
Class II — GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor t...
View Source
FDA Device Recall: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C
2024-10-16
Class II — GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The is...
View Source
FDA Device Recall: GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processin
2024-10-02
Class II — GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can re...
View Source
FDA Device Recall: ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE,
2024-09-25
Class II — The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a pot...
View Source
FDA Recall: GE Healthcare — Class II
20231101
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS | Product: Centricity PACS-IW with Universal View...
View Source
FDA Device Recall: Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundati
2023-11-01
Class II — GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Uni...
View Source
FDA Device Recall: Universal Viewer Workflow Manager, Image processing radiological system
2023-11-01
Class II — When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a dif...
View Source
FDA Device Recall: Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiol
2023-11-01
Class II — GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Uni...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220803
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verif | Product: Centricity PACS Software Version 7.0 S...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220727
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acou | Product: SIGNA Premier magnetic resonance scann...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220713
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) | Product: GE Centricity Universal Viewer Zero Footprint. To view, communicate, proc...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220706
Backup batteries can fail earlier than their estimated life. | Product: Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after Apri
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220420
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. | Product: MUSE Cardiology Information System, Model Numbers: a) 3...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220413
There is potential for the images to be flipped left to right. | Product: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220216
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | Product: GE Healthcare MR superconducting magnets, a component of GE 0...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220202
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to batter | Product: GE Vscan Extend, being sold as "Vscan ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20220202
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to batter | Product: GE Vscan Extend, being sold as "Vscan ...
View Source
FDA Device Recall: (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Uni
2022-08-31
Class II — Inaccurate Distance and Area measurements with use of Global Stack viewport.
View Source
FDA Device Recall: Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700,
2022-08-17
Class II — As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate...
View Source
FDA Device Recall: Centricity PACS Software Version 7.0 SP0.0.4.7
2022-08-03
Class II — The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
View Source
FDA Device Recall: SIGNA Premier magnetic resonance scanner, model 5748519.
2022-07-27
Class II — Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead...
View Source
FDA Device Recall: GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance
2022-07-27
Class I — There is a potential reversal of the O2 and air cylinder pressure transducer connections.
View Source
FDA Device Recall: GE Centricity Universal Viewer Zero Footprint. To view, communicate, process,
2022-07-13
Class II — Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
View Source
FDA Device Recall: Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactur
2022-07-06
Class II — Backup batteries can fail earlier than their estimated life.
View Source
FDA Device Recall: Centricity Radiology RA600
2022-06-15
Class II — Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display ina...
View Source
FDA Device Recall: Centricity Universal Viewer Zero Footprint Client
2022-06-15
Class II — Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display ina...
View Source
FDA Device Recall: Centricity Enterprise Web
2022-06-15
Class II — Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display ina...
View Source
FDA Device Recall: Replacement back up batteries distributed on or after April 1, 2019, for CARESCA
2022-06-15
Class I — Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
View Source
FDA Device Recall: GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SI
2022-04-27
Class II — During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, lead...
View Source
FDA Device Recall: MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-4
2022-04-20
Class II — Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
View Source
FDA Device Recall: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
2022-04-13
Class II — There is potential for the images to be flipped left to right.
View Source
FDA Device Recall: SIGNA Excite 3T. Magnetic Resonance Imaging System
2022-04-13
Class II — There is potential for the images to be flipped left to right.
View Source
FDA Device Recall: 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
2022-04-13
Class II — There is potential for the images to be flipped left to right.
View Source
FDA Device Recall: Revolution Apex, Revolution CT with Apex Edition
2022-04-13
Class II — The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
View Source
FDA Device Recall: 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile.
2022-04-13
Class II — There is potential for the images to be flipped left to right.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Art
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voy
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Arc
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pio
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGN
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX Sy
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Inf
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR3
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pre
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR3
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Hor
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (
2022-02-16
Class II — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Dual USB"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Sector USB"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Console"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Device Recall: GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
2022-02-02
Class II — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20211027
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. | Product: SIGNA Pioneer nuclear magnetic resonance imaging system
View Source
FDA Recall: GE Healthcare, LLC — Class II
20210929
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | Product: Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical i...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20210714
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confi | Product: The system is intended to produce cros...
View Source
FDA Device Recall: SIGNA Pioneer nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: Optima MR450w 1.5T nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: SIGNA Architect nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: Discovery MR750w 3.0T nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: SIGNA Voyager nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: SIGNA Artist nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: Discovery MR750 3.0T nuclear magnetic resonance imaging system
2021-10-27
Class II — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
View Source
FDA Device Recall: Flow sensors that may be installed in the following GEHC anesthesia machines:
2021-10-06
Class II — The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially le...
View Source
FDA Device Recall: Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that dis
2021-09-29
Class II — Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
View Source
FDA Device Recall: Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displ
2021-09-29
Class II — Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
View Source
FDA Device Recall: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
2021-08-04
Class II — Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
View Source
FDA Device Recall: SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner design
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: SIGNA Artist, Nuclear Magnetic Resonance Imaging System
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuc
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanne
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
2021-07-21
Class II — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the ...
View Source
FDA Device Recall: The system is intended to produce cross-sectional images of the body by computer
2021-07-14
Class II — When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added...
View Source
FDA Device Recall: Revolution CT
2021-07-14
Class II — GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivere...
View Source
FDA Device Recall: Revolution EVO, Optima CT660, Optima CT680 CT Systems.
2021-07-07
Class II — Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
View Source
FDA Device Recall: GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124
2021-06-23
Class II — The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor disp...
View Source
FDA Device Recall: NM/CT 860 Nuclear Medicine / CT Scanners
2021-05-19
Class II — GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation ex...
View Source
FDA Device Recall: System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
2021-02-24
Class II — GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be...
View Source
FDA Device Recall: GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) Sy
2021-02-17
Class II — GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspensio...
View Source
FDA Device Recall: GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for gener
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Device Recall: Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM C
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Device Recall: Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discov
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Device Recall: GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general N
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Device Recall: GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general N
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Device Recall: Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nucl
2021-01-20
Class II — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
View Source
FDA Recall: GE Healthcare, LLC — Class II
20201230
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling | Product: Revolution CT ES - Product Usage: intended for head, whole body, cardiac a...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20201230
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling | Product: Revolution CT with Apex Edition CT System - Product Usage: intended for h...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20201216
Incorrect patient identification and/or patient demographic errors. | Product: MAC VU360, Electrocardiograph
View Source
FDA Recall: Ge Healthcare — Class II
20200909
GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States | Product: The OEC 9900 C-Arm is designed to prov...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20200624
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, | Product: Giraffe Incubator with installed Servo...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20200506
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | Product: Lunar iDXA bone densitometer
View Source
FDA Recall: GE Healthcare, LLC — Class II
20200506
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | Product: Lunar iDXA Advance (iDXA with enCORE v...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20200129
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series | Product: Centricity Universal Viewer 6.0, a dev...
View Source
FDA Recall: GE Healthcare, LLC — Class I
20200122
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the | Product: CARESCAPE Respiratory Module E-sCAiOV
View Source
FDA Recall: GE Healthcare, LLC — Class I
20200122
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the | Product: Airway Gas Option N-CAiO
View Source
FDA Device Recall: Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vas
2020-12-30
Class II — A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
View Source
FDA Device Recall: Revolution CT with Apex Edition CT System - Product Usage: intended for head, wh
2020-12-30
Class II — A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
View Source
FDA Device Recall: MAC VU360, Electrocardiograph
2020-12-16
Class II — Incorrect patient identification and/or patient demographic errors.
View Source
FDA Device Recall: Flow Sensor Service Part, Catalog 2089610-001-S
2020-11-11
Class II — Flow sensors could have damaged tubes in the form of small punctures or cuts.
View Source
FDA Device Recall: Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia Sy
2020-11-11
Class II — Flow sensors could have damaged tubes in the form of small punctures or cuts.
View Source
FDA Device Recall: 9100c NXT system - Product Usage: Device is licensed and distributed outside of
2020-11-11
Class II — Flow sensors could have damaged tubes in the form of small punctures or cuts.
View Source
FDA Device Recall: GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provid
2020-11-11
Class II — Flow sensors could have damaged tubes in the form of small punctures or cuts.
View Source
FDA Device Recall: Flow Sensor Service Part, Catalog 2096513-001-S
2020-11-11
Class II — Flow sensors could have damaged tubes in the form of small punctures or cuts.
View Source
FDA Device Recall: Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usag
2020-11-04
Class II — There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
View Source
FDA Device Recall: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magn
2020-10-28
Class II — Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
View Source
FDA Device Recall: NM/CT 850 Model Number: H3907AD
2020-09-30
Class II — Rotor bearing screws were found loose on detector.
View Source
FDA Device Recall: Discovery NM 630 Model # H3101RH
2020-09-30
Class II — Rotor bearing screws were found loose on detector.
View Source
FDA Device Recall: Discovery NM670 Pro Model # H3100XB
2020-09-30
Class II — Rotor bearing screws were found loose on detector.
View Source
FDA Device Recall: The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of t
2020-09-09
Class II — GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Eng...
View Source
FDA Device Recall: CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-pa
2020-08-12
Class II — CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
View Source
FDA Device Recall: CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE
2020-07-01
Class II — The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and i...
View Source
FDA Device Recall: Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
2020-06-24
Class II — Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referre...
View Source
FDA Device Recall: Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
2020-06-24
Class II — Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referre...
View Source
FDA Device Recall: System, Tomography Computed Emmission
2020-06-10
Class II — GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the U...
View Source
FDA Device Recall: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN:
2020-06-03
Class II — During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
View Source
FDA Device Recall: Lunar iDXA bone densitometer
2020-05-06
Class II — An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
View Source
FDA Device Recall: Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
2020-05-06
Class II — An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
View Source
FDA Device Recall: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
2020-05-06
Class II — An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
View Source
FDA Device Recall: SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a
2020-02-05
Class II — It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header ...
View Source
FDA Device Recall: SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a wh
2020-02-05
Class II — It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header ...
View Source
FDA Device Recall: SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a wh
2020-02-05
Class II — It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header ...
View Source
FDA Device Recall: Centricity Universal Viewer 6.0, a device that displays medical images and data
2020-01-29
Class II — Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lea...
View Source
FDA Device Recall: Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to
2020-01-29
Class I — GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and t...
View Source
FDA Device Recall: CARESCAPE Respiratory Module E-sCAiOV
2020-01-22
Class I — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
View Source
FDA Device Recall: Airway Gas Option N-CAiO
2020-01-22
Class I — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
View Source
FDA Device Recall: CARESCAPE Respiratory Module E-sCAiO
2020-01-22
Class I — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
View Source
FDA Device Recall: CARESCAPE Respiratory Module E-sCAiOVE
2020-01-22
Class I — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
View Source
FDA Device Recall: ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intend
2020-01-01
Class II — When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Stati...
View Source
FDA Device Recall: CIC Pro Clinical Information Center Central Station - Product Usage: The intende
2020-01-01
Class II — When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Stati...
View Source
FDA Device Recall: CARESCAPE Central Station - Product Usage: The intended use is to provide clinic
2020-01-01
Class II — When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Stati...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20191225
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insuff | Product: Aestiva 7900, Model Numbers: a) 1006-...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190731
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s bar | Product: MAC VU360, Model Number 2030360-001, E...
View Source
FDA Recall: GE Healthcare, LLC — Class III
20190703
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillat | Product: Leadwire sets with snap ends: REF/Cat...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190619
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | Product: Prestilix 1600X Prestilix system is a fully integrated r...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190619
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | Product: Prestige II, Prestige SI, Prestige VH Prestige system is ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190508
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, | Product: NM/CT 870 CZT, Model/Catalogue/Code # ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190508
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, | Product: NM/CT 870 DR Product Usage: The GE...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190213
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors | Product: GE Healthcare Centricity Universal V...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20190206
Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific prob | Product: GE HEALTHCARE LOGIQ P6 Premium TruScan...
View Source
FDA Device Recall: Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-
2019-12-25
Class II — Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may pr...
View Source
FDA Device Recall: Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 10
2019-12-25
Class II — Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may pr...
View Source
FDA Device Recall: Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-932
2019-12-25
Class II — Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may pr...
View Source
FDA Device Recall: Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-00
2019-12-25
Class II — Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may pr...
View Source
FDA Device Recall: Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
2019-12-11
Class I — Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient f...
View Source
FDA Device Recall: Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as a
2019-11-13
Class II — Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
View Source
FDA Device Recall: Achilles Express Bone Sonometer
2019-10-16
Class II — Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth con...
View Source
FDA Device Recall: Achilles Insight Bone Sonometer
2019-10-16
Class II — Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth con...
View Source
FDA Device Recall: GE Senographe Pristina - Product Usage: Senographe Pristina generates digital ma
2019-08-07
Class II — Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
View Source
FDA Device Recall: MAC VU360, Model Number 2030360-001, Electrocardiograph
2019-07-31
Class II — Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report...
View Source
FDA Device Recall: Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
2019-07-24
Class II — Potential for a transducer mis-alignment in certain transvaginal probes.
View Source
FDA Device Recall: Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-
2019-07-24
Class II — Potential for a transducer mis-alignment in certain transvaginal probes.
View Source
FDA Device Recall: Revolution CT scanners Product Usage: The system is intended for head, whole
2019-07-24
Class II — Additional low dose radiation exposure.
View Source
FDA Device Recall: Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a
2019-07-17
Class I — The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the mane...
View Source
FDA Device Recall: Centricity Universal Viewer 6.0 Is a device that displays medical images and
2019-07-10
Class II — There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
View Source
FDA Device Recall: Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG L
2019-07-03
Class III — ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
View Source
FDA Device Recall: Replacement leadwires with grabber ends: REF/Catalog Number Description 210638
2019-07-03
Class III — ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
View Source
FDA Device Recall: ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable,
2019-07-03
Class III — ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
View Source
FDA Device Recall: Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001
2019-07-03
Class II — There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
View Source
FDA Device Recall: Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-00
2019-07-03
Class II — There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
View Source
FDA Device Recall: Discovery Ml DR Product Usage: The systems are intended for head and whole b
2019-06-26
Class II — GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
View Source
FDA Device Recall: Discovery Ml Product Usage: The systems are intended for head and whole bod
2019-06-26
Class II — GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
View Source
FDA Device Recall: Prestilix 1600X Prestilix system is a fully integrated remote controlled di
2019-06-19
Class II — There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
View Source
FDA Device Recall: Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose
2019-06-19
Class II — There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
View Source
FDA Device Recall: Silhouette VR This fully integrated system offers intuitive controls with ad
2019-06-19
Class II — There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
View Source
FDA Device Recall: Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to
2019-06-19
Class II — There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
View Source
FDA Device Recall: GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa
2019-06-19
Class II — There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
View Source
FDA Device Recall: NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discover
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical t
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended f
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector n
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuc
2019-05-08
Class II — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one de...
View Source
FDA Device Recall: Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoro
2019-04-24
Class II — There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal...
View Source
FDA Device Recall: Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG
2019-04-03
Class III — The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
View Source
FDA Device Recall: GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Univer
2019-02-13
Class II — When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient sel...
View Source
FDA Device Recall: GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09
2019-02-06
Class II — Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
View Source
FDA Device Recall: Discover VH/Millennium VG Nuclear Medicine Imaging System
2019-01-16
Class II — A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocke...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20181226
Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and v | Product: Centricity Universal Viewer Zero Footp...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20181219
Patient monitors may restart due to network overload caused by network configuration. | Product: PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portab
View Source
FDA Recall: GE Healthcare, LLC — Class I
20181212
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation | Product: GE HEALTHCARE CARESCAPE R860 Inspirato...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20181121
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode | Product: Aisys Anesthesia System. Sold under t...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20181121
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode | Product: Aisys CS2 Anesthesia System. Sold und...
View Source
FDA Recall: GE Healthcare, LLC — Class I
20181121
A detector can detach and fall. | Product: GE Healthcare Millennium MC
View Source
FDA Recall: GE Healthcare, LLC — Class II
20181024
Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. | Product: Centricity Universal Viewer with Cross Enterprise Display This impacts product ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20180808
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptib | Product: CT Goldseal Optima CT 600
View Source
FDA Recall: GE Healthcare, LLC — Class II
20180808
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptib | Product: Revolution EVO 3.6, labeled as a. H...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20180808
DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninterupti | Product: Discovery MI Digital Ready
View Source
FDA Recall: GE Healthcare — Class II
20180613
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. | Product: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Cen...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20180404
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. | Product: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended ...
View Source
FDA Device Recall: Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Sof
2018-12-26
Class II — Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appe...
View Source
FDA Device Recall: PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Mon
2018-12-19
Class II — Patient monitors may restart due to network overload caused by network configuration.
View Source
FDA Device Recall: Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, loca
2018-12-19
Class II — When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could resu...
View Source
FDA Device Recall: B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable mu
2018-12-19
Class II — Patient monitors may restart due to network overload caused by network configuration.
View Source
FDA Device Recall: B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable mul
2018-12-19
Class II — Patient monitors may restart due to network overload caused by network configuration.
View Source
FDA Device Recall: GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for
2018-12-19
Class II — There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
View Source
FDA Device Recall: PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. T
2018-12-19
Class II — Patient monitors may restart due to network overload caused by network configuration.
View Source
FDA Device Recall: Discovery NM/CT 670 Pro, model 5376204-70-54
2018-12-19
Class II — When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could resu...
View Source
FDA Device Recall: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713
2018-12-12
Class I — The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation...
View Source
FDA Device Recall: Dash 5000 Patient Monitoring System is used to monitor physiologic parameter dat
2018-12-05
Class II — The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
View Source
FDA Device Recall: Solar 9500 Information Monitoring System is used to monitor physiologic paramet
2018-12-05
Class II — The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
View Source
FDA Device Recall: Solar 8000M Patient Monitoring System is used to monitor physiologic parameter
2018-12-05
Class II — The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
View Source
FDA Device Recall: Dash 3000 Patient Monitoring System is used to monitor physiologic parameter dat
2018-12-05
Class II — The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
View Source
FDA Device Recall: Giraffe Incubator Carestation. Neonatal incubator. Device sold under the follow
2018-11-28
Class II — Potential electric leakage affecting the user.
View Source
FDA Device Recall: Panda Freestanding Warmer. Device sold under the following product names: Panda
2018-11-28
Class II — Potential electric leakage affecting the user.
View Source
FDA Device Recall: Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following
2018-11-28
Class II — Potential electric leakage affecting the user.
View Source
FDA Device Recall: Giraffe Warmer. Device sold under the following product names: Giraffe Warmer an
2018-11-28
Class II — Potential electric leakage affecting the user.
View Source
FDA Device Recall: Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS
2018-11-21
Class II — Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV ba...
View Source
FDA Device Recall: Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AI
2018-11-21
Class II — Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV ba...
View Source
FDA Device Recall: GE Healthcare Millennium MC
2018-11-21
Class I — A detector can detach and fall.
View Source
FDA Device Recall: GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camer
2018-11-21
Class I — A detector can detach and fall.
View Source
FDA Device Recall: Touchscreen display kit. Sold under the following product names: TOUCHSCREEN D
2018-11-21
Class II — Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV ba...
View Source
FDA Device Recall: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acqu
2018-11-21
Class I — A detector can detach and fall.
View Source
FDA Device Recall: Centricity Universal Viewer with Cross Enterprise Display This impacts product v
2018-10-24
Class II — Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
View Source
FDA Device Recall: CT Goldseal Optima CT 600
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAU
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Discovery MI Digital Ready
2018-08-08
Class II — DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Optima CT 520
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Optima CT 540
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Revolution CT 160 1.5D STD WAUK
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ri
2018-08-08
Class II — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
View Source
FDA Device Recall: Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
2018-08-01
Class II — The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
View Source
FDA Device Recall: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity P
2018-06-13
Class II — Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
View Source
FDA Device Recall: Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage
2018-04-11
Class II — if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrec...
View Source
FDA Device Recall: Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Produc
2018-04-11
Class II — if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorre...
View Source
FDA Device Recall: GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-0
2018-04-11
Class II — A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more imag...
View Source
FDA Device Recall: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to
2018-04-04
Class II — Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
View Source
FDA Device Recall: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery
2018-04-04
Class II — Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
View Source
FDA Recall: GE Healthcare, LLC — Class II
20170621
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | Product: GE Healthcare Optima CT520 X-ray system
View Source
FDA Recall: GE Healthcare, LLC — Class II
20170621
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). | Product: Infant Warmer System (IWS)
View Source
FDA Recall: GE Healthcare, LLC — Class II
20170104
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy | Product: Prestige VH
View Source
FDA Recall: GE Healthcare, LLC — Class II
20170104
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy | Product: Precision 500D
View Source
FDA Recall: GE Healthcare, LLC — Class II
20170104
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy | Product: ADVANTX LCA
View Source
FDA Device Recall: Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
2017-07-19
Class II — Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
View Source
FDA Device Recall: GE Healthcare Optima CT520 X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: Infant Warmer System (IWS)
2017-06-21
Class II — GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of t...
View Source
FDA Device Recall: GE Healthcare lnnova IGS 540 ACT X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare BrightSpeed X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare Discovery NM/CT 570c X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare Discovery Ml DR X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare Optima CT540 X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: GE Healthcare Discovery IQ X-ray system
2017-06-21
Class II — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
View Source
FDA Device Recall: Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
2017-06-07
Class II — Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
View Source
FDA Device Recall: Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
2017-04-19
Class II — GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. T...
View Source
FDA Device Recall: Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
2017-04-19
Class II — GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. T...
View Source
FDA Device Recall: Infant Warmer System (IWS)
2017-01-18
Class II — GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the...
View Source
FDA Device Recall: Prestige VH
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: Precision 500D
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: ADVANTX LCA
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: Prestige SI
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: RFX
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: ADVANTX LCV+
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: Prestilix
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: Innova 2000
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: Legacy
2017-01-04
Class II — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 20...
View Source
FDA Device Recall: GE Healthcare, Avance, Avance CS2, Amingo.
2016-12-21
Class II — GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage ...
View Source
FDA Device Recall: GE Healthcare, Discovery MR750w
2016-07-13
Class II — GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible ...
View Source
FDA Device Recall: GE Revolution CT The system is intended for head, whole body, cardiac and vas
2016-06-15
Class II — GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can des...
View Source
FDA Recall: GE Healthcare — Class II
20151111
Inaccurate distance measurements with magnified projection X-ray images. | Product: The Centricity Universal Viewer Version is a device that displays medical images (including mammogra
View Source
FDA Recall: GE Healthcare — Class II
20151014
Images may be missing when a system parameter MapRoute is set to a value greater than 1. | Product: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical im...
View Source
FDA Recall: GE Healthcare — Class II
20150930
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. | Product: Lightspeed 16 CT
View Source
FDA Recall: GE Healthcare — Class II
20150902
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a | Product: Centricity Universal Viewer Product...
View Source
FDA Recall: GE Healthcare — Class II
20150729
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affec | Product: GE Healthcare Precision 500D Classical...
View Source
FDA Recall: GE Healthcare — Class II
20150708
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD | Product: GE Healthcare Precision 500D and Advan...
View Source
FDA Recall: GE Healthcare — Class II
20150708
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Inte | Product: GE Healthcare Optima IGS 320. Angio...
View Source
FDA Recall: GE Healthcare — Class II
20150603
A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Mod | Product: D-fend, (p/n 876446-HEL), and D-fend+ ...
View Source
FDA Recall: GE Healthcare — Class II
20150527
GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 C | Product: CT LightSpeed 16 and Discovery ST Pet/...
View Source
FDA Recall: GE Healthcare — Class II
20150401
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites. | Product: GE Healthcare, SIGNA 1.5T TWINSPEED, S...
View Source
FDA Recall: GE Healthcare — Class II
20150325
Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills. | Product: GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part number...
View Source
FDA Recall: GE Healthcare — Class II
20150318
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky | Product: GE Healthcare Proteus XR/a with wall s...
View Source
FDA Recall: GE Healthcare — Class II
20150121
GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in t | Product: GE Healthcare, Proteus XR/a with wall ...
View Source
FDA Device Recall: GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0
2015-11-18
Class II — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the mod...
View Source
FDA Device Recall: GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging dev
2015-11-18
Class II — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the mod...
View Source
FDA Device Recall: GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and
2015-11-18
Class II — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the mod...
View Source
FDA Device Recall: GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system
2015-11-18
Class II — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the mod...
View Source
FDA Device Recall: GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a wh
2015-11-18
Class II — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the mod...
View Source
FDA Device Recall: The Centricity Universal Viewer Version is a device that displays medical images
2015-11-11
Class II — Inaccurate distance measurements with magnified projection X-ray images.
View Source
FDA Device Recall: The Centricity PACS-IW with Universal Viewer is a device that displays medical i
2015-11-11
Class II — Inaccurate distance measurements with magnified projection X-ray images.
View Source
FDA Device Recall: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that r
2015-10-14
Class II — Images may be missing when a system parameter MapRoute is set to a value greater than 1.
View Source
FDA Device Recall: Lightspeed 16 CT
2015-09-30
Class II — Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
View Source
FDA Device Recall: PET Discovery LS
2015-09-30
Class II — Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
View Source
FDA Device Recall: PET Discovery ST 16
2015-09-30
Class II — Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
View Source
FDA Device Recall: Centricity Universal Viewer Product Usage: The Centricity Universal Viewer V
2015-09-02
Class II — Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
View Source
FDA Device Recall: Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-
2015-09-02
Class II — Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
View Source
FDA Device Recall: GE Healthcare Precision 500D Classical R & F system.
2015-07-29
Class II — A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor susp...
View Source
FDA Device Recall: GE Healthcare Precision RXi 23A/32A Analog System
2015-07-29
Class II — A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor susp...
View Source
FDA Device Recall: GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoro
2015-07-08
Class II — The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight ca...
View Source
FDA Device Recall: GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating f
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generatin
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating f
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fl
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating f
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fl
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating f
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating f
2015-07-08
Class II — GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Opt...
View Source
FDA Device Recall: GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blo
2015-07-01
Class II — GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
View Source
FDA Device Recall: D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Co
2015-06-03
Class II — A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 m...
View Source
FDA Device Recall: CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed t
2015-05-27
Class II — GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In th...
View Source
FDA Device Recall: GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
2015-05-20
Class II — The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not...
View Source
FDA Device Recall: GE Discovery MR950 MRI system
2015-05-13
Class II — The alignment lasers are missing the labels required by radiation safety regulations.
View Source
FDA Device Recall: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
2015-05-06
Class II — An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
View Source
FDA Device Recall: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
2015-05-06
Class II — An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
View Source
FDA Device Recall: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
2015-05-06
Class II — An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
View Source
FDA Device Recall: Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT
2015-04-22
Class II — GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed p...
View Source
FDA Device Recall: GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINI
2015-04-01
Class II — GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
View Source
FDA Device Recall: GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers
2015-03-25
Class II — Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
View Source
FDA Device Recall: GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model num
2015-03-25
Class II — Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
View Source
FDA Device Recall: GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems,
2015-03-25
Class II — GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injurie...
View Source
FDA Device Recall: GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for
2015-03-18
Class II — Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result...
View Source
FDA Device Recall: This correction applies to all GE Healthcare MRI systems with superconducting ma
2015-02-25
Class I — At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in ...
View Source
FDA Device Recall: GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
2015-01-21
Class II — GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray ima...
View Source
FDA Device Recall: GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The
2015-01-21
Class II — Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
View Source
FDA Device Recall: GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
2015-01-21
Class II — Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
View Source
FDA Recall: GE Healthcare, LLC — Class II
20141119
GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the | Product: Discovery NM 630, dual detector free-g...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140917
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respirato | Product: CARESCAPE Respiratory Modules E-sCO, E...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140827
GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall | Product: GE Healthcare, Discovery XR656P/N 5374...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140709
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the | Product: GE Healthcare, Revolution XR/d. Re...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140709
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the | Product: GE Healthcare, Proteus XR/a. Proteu...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140625
Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may | Product: GE Healthcare, Compact Airway Modules ...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140611
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and | Product: Kenex Radiation Shield and surgical la...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140319
Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failu | Product: Elscint APEX Helix, dual-head, multi-p...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20140319
GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays aft | Product: GE Healthcare, Innova 2100IQ, Innova 3...
View Source
FDA Device Recall: Innova IGS 540 Indicated for use for patients from newborn to geriatric in ge
2014-12-24
Class II — Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism...
View Source
FDA Device Recall: Discovery IGS 740 Indicated for use for patients from newborn to geriatric in
2014-12-24
Class II — Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism...
View Source
FDA Device Recall: Discovery NM 630, dual detector free-geometry integrated nuclear imaging system.
2014-11-19
Class II — GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check ...
View Source
FDA Device Recall: Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging syste
2014-11-19
Class II — GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to t...
View Source
FDA Device Recall: Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM
2014-11-19
Class II — GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to t...
View Source
FDA Device Recall: Brivo NM615, is an all-purpose, single detector integrated nuclear imaging syste
2014-11-19
Class II — GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to t...
View Source
FDA Device Recall: GE Healthcare Carescape Patient Data Module
2014-10-15
Class II — GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescap...
View Source
FDA Device Recall: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAi
2014-09-17
Class II — GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and t...
View Source
FDA Device Recall: GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digita
2014-08-27
Class II — GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reporte...
View Source
FDA Device Recall: DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-
2014-07-30
Class I — Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair cl...
View Source
FDA Device Recall: GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
2014-07-30
Class II — Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 ...
View Source
FDA Device Recall: GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intende
2014-07-30
Class II — Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the s...
View Source
FDA Device Recall: GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution
2014-07-09
Class II — GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray ...
View Source
FDA Device Recall: GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use i
2014-07-09
Class II — GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray ...
View Source
FDA Device Recall: GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E
2014-06-25
Class II — Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause lo...
View Source
FDA Device Recall: Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interven
2014-06-11
Class II — GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not relat...
View Source
FDA Device Recall: The Centricity PACS Workstation is intended for use as a primary diagnostic and
2014-06-04
Class II — It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active dis...
View Source
FDA Device Recall: GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: Th
2014-05-28
Class II — When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of...
View Source
FDA Device Recall: Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared
2014-05-14
Class II — Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregi...
View Source
FDA Device Recall: GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext
2014-05-07
Class II — GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
View Source
FDA Device Recall: GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equ
2014-05-07
Class II — GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/...
View Source
FDA Device Recall: GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized
2014-04-30
Class II — GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may res...
View Source
FDA Device Recall: GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 1
2014-03-26
Class II — GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. ...
View Source
FDA Device Recall: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Pr
2014-03-19
Class II — Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single s...
View Source
FDA Device Recall: GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 41
2014-03-19
Class II — GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which ma...
View Source
FDA Device Recall: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use
2014-03-19
Class II — Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single s...
View Source
FDA Device Recall: GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4,
2014-03-12
Class II — GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will sto...
View Source
FDA Device Recall: GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeS
2014-03-12
Class II — When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICO...
View Source
FDA Device Recall: GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Rad
2014-03-05
Class II — GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital R...
View Source
FDA Device Recall: GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The
2014-03-05
Class I — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
View Source
FDA Device Recall: GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stan
2014-03-05
Class I — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
View Source
FDA Device Recall: GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 D
2014-02-26
Class II — GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulti...
View Source
FDA Device Recall: GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690
2014-02-26
Class II — GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery ...
View Source
FDA Device Recall: GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging system
2014-02-12
Class II — GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (...
View Source
FDA Device Recall: Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122362
2014-02-12
Class II — Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
View Source
FDA Device Recall: Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 20637
2014-02-12
Class II — Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
View Source
FDA Device Recall: Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in p
2014-02-12
Class II — Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
View Source
FDA Device Recall: Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare
2014-02-12
Class II — Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
View Source
FDA Device Recall: CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended f
2014-02-12
Class II — There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter a...
View Source
FDA Device Recall: GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAP
2014-02-05
Class II — GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-Inva...
View Source
FDA Device Recall: GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging
2014-02-05
Class II — GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potentia...
View Source
FDA Device Recall: GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended
2014-02-05
Class II — There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images ...
View Source
FDA Device Recall: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare
2014-01-29
Class II — Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and a...
View Source
FDA Device Recall: GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The T
2014-01-29
Class II — Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and a...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20131023
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the | Product: GE Healthcare, Precision 500D, Legacy,...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20131009
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, a | Product: GE Healthcare, Discovery MR750 3.0T, O...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130925
GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain | Product: GE Healthcare, Seno Advantage, 5183685...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130918
GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of th | Product: Tec 6 continuous Flow Vaporizer and Te...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130508
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images fro | Product: GE Healthcare, Optima MR360/Brivo MR35...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130424
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results | Product: GE Healthcare, AW Server. Product U...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130320
A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ | Product: GE Healthcare Advantx, Innova2000, Inn...
View Source
FDA Recall: GE Healthcare, LLC — Class I
20130220
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. | Product: Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscita...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20130220
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries | Product: GE Healthcare, CARESCAPE Monitor B650....
View Source
FDA Device Recall: Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposabl
2013-12-25
Class I — GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
View Source
FDA Device Recall: GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound s
2013-11-27
Class II — GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E...
View Source
FDA Device Recall: GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM
2013-11-27
Class II — GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM...
View Source
FDA Device Recall: AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE
2013-11-20
Class II — GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share o...
View Source
FDA Device Recall: GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intende
2013-10-23
Class II — GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist han...
View Source
FDA Device Recall: GE, Optima CT660. Intended to produce cross-sectional images of the body by c
2013-10-23
Class II — GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discover...
View Source
FDA Device Recall: GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5
2013-10-09
Class II — GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yello...
View Source
FDA Device Recall: GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the follow
2013-10-02
Class II — GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Sav...
View Source
FDA Device Recall: GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685
2013-09-25
Class II — GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact pa...
View Source
FDA Device Recall: GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angi
2013-09-25
Class II — GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 I...
View Source
FDA Device Recall: GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas wit
2013-09-25
Class II — GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software lic...
View Source
FDA Device Recall: GE Healthcare, Advantage Workstation, READY View Application. Image analysis
2013-09-25
Class II — GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
View Source
FDA Device Recall: Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Date
2013-09-18
Class II — GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The...
View Source
FDA Device Recall: GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intend
2013-09-04
Class II — GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH,...
View Source
FDA Device Recall: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcar
2013-09-04
Class II — GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH,...
View Source
FDA Device Recall: GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used
2013-09-04
Class II — GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporti...
View Source
FDA Device Recall: GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed
2013-08-28
Class II — GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the lockin...
View Source
FDA Device Recall: GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray s
2013-08-21
Class II — GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of...
View Source
FDA Device Recall: SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPE
2013-08-21
Class II — Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed a...
View Source
FDA Device Recall: GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a gen
2013-08-07
Class II — GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
View Source
FDA Device Recall: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera
2013-07-31
Class I — GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System...
View Source
FDA Device Recall: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended
2013-07-31
Class I — GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System...
View Source
FDA Device Recall: Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging syste
2013-07-31
Class I — GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System...
View Source
FDA Device Recall: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended
2013-07-31
Class I — GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System...
View Source
FDA Device Recall: CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a m
2013-07-03
Class II — GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB c...
View Source
FDA Device Recall: Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M10
2013-06-12
Class II — GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, ...
View Source
FDA Device Recall: GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR Sys
2013-05-08
Class II — GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with ap...
View Source
FDA Device Recall: MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic ima
2013-05-08
Class II — Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
View Source
FDA Device Recall: GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspee
2013-05-08
Class II — Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry ...
View Source
FDA Device Recall: Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resona
2013-05-08
Class II — Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
View Source
FDA Device Recall: GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic
2013-05-08
Class II — GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with ap...
View Source
FDA Device Recall: GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, proces
2013-05-01
Class II — GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT sc...
View Source
FDA Device Recall: GE Healthcare, AW Server. Product Usage: . AW Server is a medical software s
2013-04-24
Class II — GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a p...
View Source
FDA Device Recall: GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product
2013-04-17
Class II — GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image fl...
View Source
FDA Device Recall: GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7
2013-04-17
Class II — GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered ...
View Source
FDA Device Recall: VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45
2013-04-17
Class II — GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety...
View Source
FDA Device Recall: GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova
2013-03-20
Class II — A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardio...
View Source
FDA Device Recall: GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-
2013-03-20
Class II — Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
View Source
FDA Device Recall: GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer
2013-03-13
Class II — Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
View Source
FDA Device Recall: GE Healthcare Definium 5000 / 5220493 X-Ray System
2013-03-06
Class II — When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposu...
View Source
FDA Device Recall: Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation
2013-02-20
Class I — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
View Source
FDA Device Recall: GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-
2013-02-20
Class II — GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the ...
View Source
FDA Device Recall: GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking stati
2013-02-20
Class II — GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops ...
View Source
FDA Device Recall: GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor
2013-02-20
Class II — GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort ...
View Source
FDA Device Recall: GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Pa
2013-01-02
Class I — Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
View Source
FDA Recall: GE Healthcare, LLC — Class II
20121128
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22O | Product: GE Healthcare Brivo XR 285 Mobile g...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20121031
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ | Product: GE Healthcare innova 3100-IQ, Mobile X...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20121031
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safet | Product: GE Healthcare, Seno Advantage 2.2 work...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20120725
GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / | Product: GE Healthcare, Invasive Blood Pressure...
View Source
FDA Recall: GE Healthcare, LLC — Class II
20120718
GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion cap | Product: GE Advantage CT/PET Fusion for Advanta...
View Source
FDA Device Recall: GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8
2012-12-26
Class II — GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
View Source
FDA Device Recall: Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and
2012-12-26
Class II — GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the c...
View Source
FDA Device Recall: GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobi
2012-12-05
Class II — GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
View Source
FDA Device Recall: GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile
2012-12-05
Class II — GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
View Source
FDA Device Recall: GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobi
2012-12-05
Class II — GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
View Source
FDA Device Recall: GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the
2012-11-28
Class II — It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Up...
View Source
FDA Device Recall: GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of
2012-11-28
Class II — It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Up...
View Source
FDA Device Recall: GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indi
2012-10-31
Class II — It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
View Source
FDA Device Recall: GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 2
2012-10-31
Class II — GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potentia...
View Source
FDA Device Recall: GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are ind
2012-10-31
Class II — It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
View Source
FDA Device Recall: GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool i
2012-10-31
Class II — GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation s...
View Source
FDA Device Recall: GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indic
2012-10-31
Class II — It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
View Source
FDA Device Recall: Optima XR220amx Mobile general purpose radiographic imaging of the human head
2012-09-19
Class II — Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing th...
View Source
FDA Device Recall: GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems
2012-09-19
Class II — GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innov...
View Source
FDA Device Recall: GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 201699
2012-07-25
Class II — GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. ...
View Source
FDA Device Recall: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT
2012-07-18
Class II — GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/...
View Source
FDA Device Recall: GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohme
2012-06-27
Class I — GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Po...
View Source
fda_adverse
2 records
FDA AE Manufacturer: GE Healthcare Inc.
Drug adverse event reporter — Product: VISIPAQUE
View Source
ny_corps
1 records
NY Corp: GE HEALTHCARE INC.
1994-09-28
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
View Source
Be informed when major changes happen on CFVA — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.