co_sos
1 records
CO Business: Philips North America LLC
1995-10-09
FLLC | Status: Good Standing | Cambridge, MA
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fda
400 records
FDA Recall: Philips North America — Class II
20260506
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, | Product: Philips SmartPath to dStream for 3.0T ...
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FDA Recall: Philips North America — Class II
20260506
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, | Product: Philips SmartPath to Ingenia Elition X...
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FDA Recall: Philips North America Llc — Class II
20260218
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these | Product: Brilliance iCT; Product Code (REF): 7...
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FDA Recall: Philips North America Llc — Class II
20260218
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these | Product: Spectral CT; Product Code (REF): 7283...
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FDA Recall: Philips North America — Class II
20260204
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication Syst | Product: SmartPath to dStream for 3.0T. Produ...
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FDA Recall: Philips North America — Class II
20260204
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication Syst | Product: Ingenia Ambition S. Product Code (RE...
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FDA Device Recall: Brilliance iCT; Product Code (REF): 728306;
2026-02-18
Class II — As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specifi...
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FDA Device Recall: Spectral CT; Product Code (REF): 728333;
2026-02-18
Class II — As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specifi...
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FDA Device Recall: IQon Spectral CT; Product Code (REF): 728332;
2026-02-18
Class II — As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specifi...
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FDA Device Recall: SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR syst
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW vers
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. M
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW versi
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Device Recall: Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R
2026-02-04
Class II — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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FDA Recall: Philips North America Llc — Class II
20251210
Potential issue where the IntelliVue monitors did not alarm. | Product: IntelliVue MP90. Product Number: M8010A.
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FDA Recall: Philips North America Llc — Class II
20251210
Potential issue where the IntelliVue monitors did not alarm. | Product: IntelliVue MP30. Product Number: M8002A.
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FDA Recall: Philips North America Llc — Class II
20251210
Potential issue where the IntelliVue monitors did not alarm. | Product: IntelliVue Patient Monitor MX800. Product Number: 865240.
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FDA Recall: Philips North America — Class II
20250806
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or | Product: Ingenia Elition X Model Numbers (REF)...
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FDA Recall: Philips North America Llc — Class II
20250702
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or p | Product: Spectral CT. Computed tomography X-ray...
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FDA Recall: Philips North America — Class II
20250618
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a pote | Product: Intera 1.5T Achieva Nova-Dual Product...
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FDA Recall: Philips North America Llc — Class II
20250528
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. | Product: Product Name: Evolution Upgrade 3.0T; Model Numbers:...
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FDA Recall: Philips North America Llc — Class II
20250514
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. | Product: Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intu...
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FDA Recall: Philips North America Llc — Class II
20250430
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation | Product: Zenition 70. Product Code 718133. The ...
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FDA Recall: Philips North America Llc — Class II
20250212
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or Intelli | Product: IntelliVue Patient Monitor MX400. Mode...
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FDA Device Recall: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTI
2025-12-17
Class II — Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FD...
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FDA Device Recall: IntelliVue MP90. Product Number: M8010A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue MP30. Product Number: M8002A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue Patient Monitor MX800. Product Number: 865240.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue Patient Monitor MX700. Product Number: 865241.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: CT 5300; Software Version Number: 4.5, 5.0, 5.1;
2025-12-10
Class II — If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within...
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FDA Device Recall: IntelliVue Patient Monitor MX500. Product Number: 866064.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue Patient Monitor MX850. Product Number: 866470.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue MP2. Product Number: M8102A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
2025-12-10
Class II — If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within...
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FDA Device Recall: IntelliVue MP50. Product Number: M8004A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue MP80. Product Number: M8008A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue Patient Monitor MX100. Product Number: 867033.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue MP40. Product Number: M8003A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue Multi Measurement Server X2. Product Number: M3002A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: IntelliVue MP60. Product Number: M8005A.
2025-12-10
Class II — Potential issue where the IntelliVue monitors did not alarm.
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FDA Device Recall: Cardiac Workstation 5000; Model Number: 860439;
2025-10-22
Class II — Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
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FDA Device Recall: Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number:
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Numbe
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 72
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, M
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Nu
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Mod
2025-10-01
Class II — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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FDA Device Recall: Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4)
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: SmartPath to dStream for 3.0T Model Number (REF): 782145;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Ingenia 1.5T S Model Number (REF): 781347;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (Chi
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Upgrade to MR 7700 Model Number (REF): 782130;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4)
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
2025-08-06
Class II — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Spectral CT. Computed tomography X-ray system.
2025-07-02
Class II — Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software ...
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FDA Device Recall: Intera 1.5T Achieva Nova-Dual Product Number: 781173;
2025-06-18
Class II — identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If ...
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FDA Device Recall: Intera 1.5T Explorer/Nova Dual Product Number: 781108;
2025-06-18
Class II — identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If ...
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FDA Device Recall: SmartPath to dStream for 1.5T¿; Product Number: 782146;
2025-06-18
Class II — identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If ...
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FDA Device Recall: Intera 1.5T Achieva IT Nova Product Number: 781175
2025-06-18
Class II — identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If ...
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FDA Device Recall: Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: Ingenia 3.0T CX; Model Number: 781271;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: Ingenia 1.5T CX; Model Number: 781262;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: Ingenia 1.5T S; Model Number: 781347;
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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FDA Device Recall: Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
View Source
FDA Device Recall: Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 78
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
View Source
FDA Device Recall: Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
View Source
FDA Device Recall: Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 78
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
View Source
FDA Device Recall: Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 78
2025-05-28
Class II — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
View Source
FDA Device Recall: Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pe
2025-05-14
Class II — Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
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FDA Device Recall: Zenition 70. Product Code 718133. The devices are used for radiological guidance
2025-04-30
Class II — A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
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FDA Device Recall: Veradius Unity. Product Code 718132. The devices are used for radiological guida
2025-04-30
Class II — A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
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FDA Device Recall: Zenition 50. Product Code 718096. The devices are used for radiological guidanc
2025-04-30
Class II — A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
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FDA Device Recall: Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomograph
2025-04-30
Class II — Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
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FDA Device Recall: Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
2025-04-23
Class II — Potential for collimator to fall as a result of incorrect installation.
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FDA Device Recall: IntelliVue Patient Monitor MX400. Model Number: 866060
2025-02-12
Class II — Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
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FDA Device Recall: IntelliVue Patient Monitor MX450. Model Number: 866062
2025-02-12
Class II — Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
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FDA Device Recall: IntelliVue Patient Monitor MX550. Model Number: 866066
2025-02-12
Class II — Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
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FDA Device Recall: IntelliVue Patient Monitor MX500. Model Number: 866064
2025-02-12
Class II — Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
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FDA Recall: Philips North America Llc — Class II
20241204
Potential safety issue where a patient may be harmed while preparing for or during a scan. | Product: dS Breast 16ch 1.5T
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FDA Recall: Philips North America Llc — Class II
20241016
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capab | Product: IntelliVue Patient Monitor MX400/MX450...
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FDA Recall: Philips North America — Class II
20241016
During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease | Product: Patient Information Center iX, Product...
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FDA Recall: Philips North America Llc — Class II
20240612
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard | Product: HA FlexTrak II-Patient transport functionality ...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: Achieva 3.0T Model Number (REF): (...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: MR system 1.5T Marlin- Magnetic Reson...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: Ingenia Ambition S Model Number (REF)...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: Ingenia Ambition X- Magnetic Resonance...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: SmartPath to dStream for 3.0T Mode...
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FDA Recall: Philips North America Llc — Class II
20240529
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit | Product: Evolution upgrade 3.0T Model Number ...
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FDA Recall: Philips North America Llc — Class II
20240522
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperat | Product: Ingenia 1.5T with Evolution Upgrade 1....
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FDA Recall: Philips North America Llc — Class II
20240522
Event Catalog information does not save when copied and transferred from one unit to another. | Product: Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Ingenia 1.5T S, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Achieva 1.5T, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Intera 1.5T Omni/Stellar, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Achieva 3.0T, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: GYROSCAN T5-NT, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Intera 1.5T, Magnetic Resonance System.
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FDA Recall: Philips North America Llc — Class II
20240424
Patient support table floor plate may be incorrectly installed. | Product: Intera 1.5T Achieva Nova, Magnetic Resonance System.
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FDA Recall: Philips North America — Class I
20240214
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, co | Product: BrightView, gamma camera system; Mo...
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FDA Recall: Philips North America — Class II
20240207
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose duri | Product: Intera 1.5T Achieva Nova. Model (REF) ...
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FDA Device Recall: Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
2024-12-25
Class II — The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially cau...
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FDA Device Recall: Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
2024-12-11
Class II — Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and ...
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FDA Device Recall: dS Breast 16ch 1.5T
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: Mammotrak Interventional Coil 3.0T
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: Mammotrak Diagnostic Coil 1.5T
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: dS Breast 7ch 3.0T
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: ST SENSE Breast Dx Coil
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: SENSE Breast Coil
2024-12-04
Class II — Potential safety issue where a patient may be harmed while preparing for or during a scan.
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FDA Device Recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01
2024-10-16
Class II — Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not...
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FDA Device Recall: Patient Information Center iX, Product Code 866386, and Patient Information Cent
2024-10-16
Class II — During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, up...
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FDA Device Recall: DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system
2024-10-09
Class II — If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the de...
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FDA Device Recall: Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images,
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional im
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional image
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectiona
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional imag
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-s
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional im
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, s
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-
2024-10-02
Class II — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the...
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FDA Device Recall: IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitle
2024-08-14
Class II — Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for soft...
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FDA Device Recall: IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitle
2024-08-14
Class II — Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for soft...
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FDA Device Recall: SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen ima
2024-07-03
Class I — Potential for coils to heat up and harm patients (burn).
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FDA Device Recall: SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen ima
2024-07-03
Class I — Potential for coils to heat up and harm patients (burn).
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FDA Device Recall: HA FlexTrak II-Patient transport functionality to transport the patient from the
2024-06-12
Class II — Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
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FDA Device Recall: HA FlexTrak-Patient transport functionality to transport the patient from the pr
2024-06-12
Class II — Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
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FDA Device Recall: HA FlexTrak-Patient transport functionality to transport the patient from the pr
2024-06-12
Class II — Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
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FDA Device Recall: Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4)
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical S
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108;
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Syste
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: SmartPath to dStream for 3.0T Model Number (REF): 782145
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicat
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems i
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indi
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Achieva 1.5T Initial system Model Number (REF): 781178
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Syste
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ind
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems ind
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems ind
2024-05-29
Class II — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smok...
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FDA Device Recall: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are M
2024-05-22
Class II — Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
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FDA Device Recall: Patient Information Center iX and Patient Information Center iX Expand, Software
2024-05-22
Class II — Event Catalog information does not save when copied and transferred from one unit to another.
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FDA Device Recall: Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are
2024-05-22
Class II — Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
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FDA Device Recall: The Oncology Essentials Package of the Spectral CT imaging system.
2024-05-08
Class II — Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
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FDA Device Recall: Ingenia 1.5T S, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva 1.5T, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T Omni/Stellar, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva 3.0T, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: GYROSCAN T5-NT, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T Achieva Nova, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.0T Omni/Stellar, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: GYROSCAN ACS-NT, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva XR, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Ingenia 1.5T CX, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Ingenia Elition S, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Ingenia Elition X, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Enterprise 1.5T, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: MR 7700, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: GYROSCAN T5, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva 3.0TX for PET, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera CV, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva 1.5T Conversion, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.5T R11, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Achieva 1.5T Initial, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Intera 1.0T Power/Pulsar, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: Evolution Upgrade 3.0T, Magnetic Resonance System.
2024-04-24
Class II — Patient support table floor plate may be incorrectly installed.
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FDA Device Recall: CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Up
2024-04-03
Class II — It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
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FDA Device Recall: Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Exp
2024-04-03
Class II — It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
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FDA Device Recall: ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R
2024-02-21
Class II — Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image e...
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FDA Device Recall: ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F)
2024-02-21
Class II — Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image ...
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FDA Device Recall: BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-di
2024-02-14
Class I — Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to ...
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FDA Device Recall: Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 98
2024-02-14
Class II — Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
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FDA Device Recall: BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482;
2024-02-14
Class I — Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to ...
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FDA Device Recall: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 98971000
2024-02-14
Class II — Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
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FDA Device Recall: BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478;
2024-02-14
Class I — Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to ...
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FDA Device Recall: Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: Achieva XR. Model (REF) Numbers 781153, 781253.
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: Achieva 1.5T Initial system. Model (REF) Numbers 781178.
2024-02-07
Class II — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to th...
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FDA Device Recall: Achieva 3.0T, Model No. 781177
2024-01-31
Class III — An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white backgroun...
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FDA Device Recall: SmartPath to dStream for 1.5T, Model No. 781260, 782112
2024-01-31
Class III — An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white backgroun...
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FDA Device Recall: Intera 1.5T, Model No. 781195
2024-01-31
Class III — An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white backgroun...
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FDA Device Recall: Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System
2024-01-24
Class II — If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in in...
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FDA Device Recall: (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Cen
2024-01-24
Class II — Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
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FDA Device Recall: BrightView X, Gamma Camera, Product Code 882478
2024-01-17
Class II — While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapme...
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FDA Device Recall: (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product
2024-01-17
Class II — The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
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FDA Device Recall: BrightView, Gamma Camera System, Product Code 882480.
2024-01-17
Class II — While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapme...
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FDA Device Recall: BrightView XCT, Gamma Camera, Product Code 882482
2024-01-17
Class II — While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapme...
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FDA Recall: Philips North America — Class II
20231122
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scan | Product: Spectral CT on Rails, Software Version...
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FDA Recall: Philips North America Llc — Class II
20231122
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and seco | Product: Brilliance CT Big Bore with software v...
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FDA Recall: Philips North America Llc — Class II
20231115
Potential for units suspended on the ceiling to fail and fall. | Product: DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radio
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FDA Recall: Philips North America Llc — Class II
20231115
Potential for units suspended on the ceiling to fail and fall. | Product: CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
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FDA Recall: Philips North America Llc — Class II
20231115
Potential for units suspended on the ceiling to fail and fall. | Product: DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radi
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FDA Recall: Philips North America Llc — Class II
20231115
Potential for units suspended on the ceiling to fail and fall. | Product: DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiograp
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FDA Recall: Philips North America Llc — Class II
20230927
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently requir | Product: Patient Information Center iX with Sof...
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FDA Device Recall: The device is a whole-body CT x-ray system. The acquired x-ray transmission data
2023-12-27
Class II — Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
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FDA Device Recall: Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7813
2023-12-20
Class I — Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the s...
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FDA Device Recall: SmartPath to dStream for 1.5T
2023-11-29
Class II — Potential component failure in the Gradient Coil could product smoke and/or fire.
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FDA Device Recall: Ingenia 1.5T CX
2023-11-29
Class II — Potential component failure in the Gradient Coil could product smoke and/or fire.
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FDA Device Recall: Achieva 1.5T
2023-11-29
Class II — Potential component failure in the Gradient Coil could product smoke and/or fire.
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FDA Device Recall: Achieva 1.5T Initial System
2023-11-29
Class II — Potential component failure in the Gradient Coil could product smoke and/or fire.
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FDA Device Recall: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
2023-11-22
Class II — This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the des...
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FDA Device Recall: Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT sc
2023-11-22
Class II — For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusi...
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FDA Device Recall: Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and
2023-11-22
Class II — For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusi...
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FDA Device Recall: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
2023-11-22
Class II — When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restart...
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FDA Device Recall: DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: DigitalDiagnost 4 High Performance, used to acquire, process, store, display and
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: DigitalDiagnost C90 Release 3, used to acquire, process, store, display and expo
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: Allura Xper IGTS Fixed Systems
2023-11-15
Class II — Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin...
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FDA Device Recall: BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery
2023-11-15
Class II — Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin...
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FDA Device Recall: Veradius Unity Mobile Surgery C-arm
2023-11-15
Class II — Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin...
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FDA Device Recall: DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and ex
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: DigitalDiagnost C90 High Performance, used to acquire, process, store, display a
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, displa
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and
2023-11-15
Class II — Potential for units suspended on the ceiling to fail and fall.
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FDA Device Recall: EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO
2023-10-11
Class II — A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
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FDA Device Recall: Patient Information Center iX with Software Version Number 4.x in the following:
2023-09-27
Class II — Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to re...
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FDA Device Recall: Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107
2023-08-16
Class II — During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used fo...
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FDA Device Recall: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgra
2023-08-16
Class II — During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used fo...
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FDA Device Recall: Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107
2023-08-16
Class II — The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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FDA Device Recall: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgra
2023-08-16
Class II — The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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FDA Device Recall: Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
2023-08-09
Class II — Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury t...
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FDA Device Recall: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product
2023-06-07
Class II — EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in pa...
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FDA Device Recall: EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Produ
2023-06-07
Class II — EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in pa...
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FDA Device Recall: ProxiDiagnost N90 R.1.0
2023-05-24
Class II — Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food an...
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FDA Device Recall: CombiDiagnost R90 R.1.0
2023-05-24
Class II — Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food an...
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FDA Device Recall: CombiDiagnost R90 R1.1
2023-05-24
Class II — Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food an...
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FDA Device Recall: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
2023-05-24
Class II — Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
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FDA Device Recall: Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 7
2023-05-10
Class II — Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and dama...
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FDA Device Recall: CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers
2023-04-19
Class II — If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire with...
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FDA Device Recall: ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers
2023-04-19
Class II — If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire with...
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FDA Device Recall: Philips DigitalDiagnost C50 -intended for use in generating radiographic images
2023-04-19
Class II — If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will...
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FDA Device Recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu
2023-04-19
Class II — If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will...
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FDA Recall: Philips North America Llc — Class II
20221214
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Product: Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
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FDA Recall: Philips North America Llc — Class II
20220126
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with t | Product: Infa-Therm Transport Mattress, Referen...
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FDA Device Recall: Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132,
2022-12-14
Class II — Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: Philips MR 7700 System, Model Number 782120
2022-12-14
Class II — Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
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FDA Device Recall: MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is
2022-10-12
Class II — Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
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FDA Device Recall: DigitalDiagnost C50 1.1
2022-09-07
Class II — Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first ex...
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FDA Device Recall: Philips Hemodynamic Application, Model Number 722463, Software Version Number: R
2022-05-18
Class II — When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, ...
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FDA Device Recall: The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing
2022-04-20
Class II — Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
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FDA Device Recall: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTAR
2022-04-13
Class II — There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area ...
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FDA Device Recall: Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS
2022-04-13
Class II — There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area ...
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FDA Device Recall: Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 72
2022-04-13
Class II — Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be ...
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FDA Device Recall: Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic
2022-03-16
Class II — Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet lo...
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FDA Device Recall: Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Lai
2022-03-16
Class II — Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet lo...
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FDA Device Recall: eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3
2022-02-09
Class II — eCareManager (eCM) Sentry Score software not approved for use
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FDA Device Recall: Infa-Therm Transport Mattress, Reference Number 989805616831 1015
2022-01-26
Class II — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distribu...
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FDA Device Recall: Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
2022-01-26
Class II — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distribu...
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FDA Device Recall: Heel Snuggler, Reference # 989805603411 99047
2022-01-26
Class II — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distribu...
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FDA Device Recall: Infant Heel Warmers w/strap, Reference # 989805603201 1223
2022-01-26
Class II — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distrib...
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FDA Device Recall: Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
2022-01-26
Class II — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distribu...
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FDA Device Recall: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with
2022-01-19
Class II — (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery p...
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FDA Recall: Philips North America Llc — Class II
20211201
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Ar | Product: Continuous CT Fluoroscopy DVI Ceiling ...
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FDA Recall: Philips North America LLC — Class II
20211020
Customers were not notified of previous recalls associated with various defibrillator models. | Product: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
View Source
FDA Recall: Philips North America Llc — Class II
20210922
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overhea | Product: The Allura Xper series is intended for...
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FDA Recall: Philips North America Llc — Class II
20210915
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could | Product: Ingenia 1.5T CX-a Magnetic Resonance M...
View Source
FDA Recall: Philips North America Llc — Class II
20210707
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Su | Product: Continuous CT Fluoroscopy DVI Ceiling ...
View Source
FDA Recall: Philips North America Llc — Class II
20210707
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Su | Product: Continuous CT Fluoroscopy DVI Ceiling ...
View Source
FDA Recall: Philips North America Llc — Class II
20210707
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Su | Product: Continuous CT Fluoroscopy DVI Ceiling ...
View Source
FDA Device Recall: Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for
2021-12-29
Class II — Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengag...
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FDA Device Recall: BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisitio
2021-12-15
Class II — Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the ...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64
2021-12-01
Class II — Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, ...
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FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 1
2021-12-01
Class II — Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, ...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF
2021-12-01
Class II — Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, ...
View Source
FDA Device Recall: Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x
2021-11-17
Class II — When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) ...
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FDA Device Recall: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
2021-10-20
Class II — Customers were not notified of previous recalls associated with various defibrillator models.
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FDA Device Recall: Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
2021-10-20
Class II — Customers were not notified of previous recalls associated with various defibrillator models.
View Source
FDA Device Recall: The Allura Xper series is intended for use on human patients to perform: "Vascul
2021-09-22
Class II — Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBT...
View Source
FDA Device Recall: The Azurion series (within the limits of the used Operation Room table) are inte
2021-09-22
Class II — Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBT...
View Source
FDA Device Recall: Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for us
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Sys
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for us
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated
2021-09-15
Class II — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
View Source
FDA Device Recall: Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for us
2021-09-01
Class II — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
View Source
FDA Device Recall: Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as
2021-09-01
Class II — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
View Source
FDA Device Recall: Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as
2021-09-01
Class II — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
View Source
FDA Device Recall: Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated f
2021-09-01
Class II — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
View Source
FDA Device Recall: Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as
2021-09-01
Class II — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
View Source
FDA Device Recall: 728333 Spectral CT 7500 -Computed Tomography X-ray system
2021-08-25
Class II — When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast vol...
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FDA Device Recall: 728332 IQon Spectral CT-Computed Tomography X-ray system
2021-08-25
Class II — When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast vol...
View Source
FDA Device Recall: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
2021-08-25
Class II — When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast vol...
View Source
FDA Device Recall: 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT U
2021-08-25
Class II — When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast vol...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 7
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 8
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Brack
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 7
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Brack
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Brack
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Brack
2021-07-07
Class II — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential ha...
View Source
FDA Device Recall: Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated Nov
2021-06-16
Class II — The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during ...
View Source
FDA Device Recall: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produc
2021-06-09
Class II — Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
View Source
FDA Device Recall: IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software
2021-06-02
Class II — Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
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FDA Device Recall: Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitor
2021-04-07
Class II — Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300...
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FDA Device Recall: TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Co
2021-02-03
Class II — The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Cent...
View Source
FDA Device Recall: Emission Computed Tomography System Image Process System - Product Usage: intend
2021-01-20
Class II — A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
View Source
FDA Recall: Philips North America, LLC — Class II
20200527
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not p | Product: Philips HeartStart XL Defibrillator/Mo...
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FDA Recall: Philips North America, LLC — Class II
20200506
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position | Product: Philips Azurion 7 M20 -XperGuide Softw...
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FDA Recall: Philips North America, LLC — Class II
20200325
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no | Product: Integris Allura 9, system codes 722018...
View Source
FDA Recall: Philips North America, LLC — Class II
20200325
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no | Product: Cardio Vascular-Allura Centron, system...
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FDA Recall: Philips North America, LLC — Class II
20200325
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no | Product: UroDiagnost Eleva, system code 708033
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FDA Recall: Philips North America, LLC — Class II
20200304
if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder wi | Product: Philips DigiTrak XT Holter Recorder So...
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FDA Device Recall: Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for m
2020-12-16
Class II — Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the pa...
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FDA Device Recall: Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Num
2020-11-04
Class II — The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. P...
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FDA Device Recall: ProxiDiagnost N90
2020-10-07
Class II — Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
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FDA Device Recall: Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Ch
2020-08-26
Class II — A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay...
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FDA Device Recall: Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product
2020-08-26
Class II — A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay...
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FDA Device Recall: Phillips Charging Station, Product #: 989803191021 - Product Usage: This chargin
2020-08-26
Class II — A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay...
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FDA Device Recall: Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A
2020-08-19
Class II — The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy sett...
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FDA Device Recall: IntelliVue MX800 patient monitor, model no. 865240
2020-07-29
Class II — Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructio...
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FDA Device Recall: EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnost
2020-07-15
Class II — Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
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FDA Device Recall: Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureS
2020-06-17
Class II — Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records reg...
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FDA Device Recall: Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The ches
2020-06-10
Class II — The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
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FDA Device Recall: Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usa
2020-06-03
Class II — HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
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FDA Device Recall: Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an ac
2020-06-03
Class II — Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The ins...
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FDA Device Recall: Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, an
2020-06-03
Class II — HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
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FDA Device Recall: Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usag
2020-05-27
Class II — The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The dev...
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FDA Device Recall: HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component o
2020-05-27
Class II — Damaged ESD bags used for storing components in Processor PCA Replacement Kits
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FDA Device Recall: Philips Zenition 70, System code 718133 - Product Usage: The devices are used fo
2020-05-20
Class II — When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If...
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FDA Device Recall: Philips Zenition 50, System code 718096 - Product Usage: The devices are used fo
2020-05-20
Class II — When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If...
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FDA Device Recall: Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
2020-05-13
Class II — The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
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FDA Device Recall: Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s
2020-05-13
Class II — The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
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FDA Device Recall: Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5
2020-05-06
Class II — When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a wa...
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FDA Device Recall: Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 -
2020-05-06
Class II — If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
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FDA Device Recall: Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software
2020-04-08
Class II — Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing...
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FDA Device Recall: Integris Allura 9, system codes 722018 722021
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: Cardio Vascular-Allura Centron, system code 722400
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: UroDiagnost Eleva, system code 708033
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: OmniDiagnost Eleva System codes 708028 708027
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M,
2020-03-25
Class II — Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjec...
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FDA Device Recall: MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: Poly G Integris H5000, System code 72246
2020-03-25
Class II — A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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FDA Device Recall: Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The D
2020-03-04
Class II — if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to fu...
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FDA Device Recall: Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips Hear
2020-03-04
Class II — M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
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FDA Device Recall: Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Mo
2020-02-26
Class II — Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
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FDA Device Recall: Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
2020-02-26
Class II — Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
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FDA Recall: Philips North America, LLC — Class II
20190717
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all po | Product: Philips HeartStart MRx devices in use ...
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FDA Recall: Philips North America, LLC — Class II
20190612
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . | Product: IntelliVue MX40 Patient Monitor, Product numbe...
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FDA Recall: Philips North America, LLC — Class II
20190522
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | Product: SureSigns VS3 NBP Temp, Product Number 863070. For moni...
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FDA Recall: Philips North America, LLC — Class II
20190403
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. | Product: MultiDiagnost-Eleva, Product codes 708032, 708...
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FDA Recall: Philips North America, LLC — Class II
20190227
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which c | Product: PageWriter TC70, Product 860315, Softw...
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FDA Device Recall: HeartStart XL+ Defibrillator/Monitor, Model 861290
2019-12-11
Class II — Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode,...
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FDA Device Recall: HeartStart XL+ Defibrillator/Monitor, Model 861290
2019-11-27
Class II — The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function;...
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FDA Device Recall: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008848
2019-10-02
Class II — The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the...
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FDA Device Recall: IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected p
2019-09-25
Class II — Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
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FDA Device Recall: HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartS
2019-09-18
Class II — Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
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FDA Device Recall: Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product U
2019-09-18
Class II — The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
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FDA Device Recall: Philips Azurion systems with software version R1.2 -Interventional Fluoroscopi
2019-08-14
Class II — The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
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FDA Device Recall: Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A,
2019-07-17
Class II — The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption ...
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FDA Device Recall: IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All oth
2019-06-12
Class II — The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
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FDA Device Recall: SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological
2019-05-22
Class II — System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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FDA Device Recall: SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physio
2019-05-22
Class II — System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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FDA Device Recall: SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the p
2019-05-22
Class II — System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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FDA Device Recall: SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiologica
2019-05-22
Class II — System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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FDA Device Recall: Fetal Spiral Electrode, Model No. 9898 031 37631
2019-05-08
Class II — During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
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FDA Device Recall: Azurion FlexArm, 722079
2019-04-17
Class II — During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
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FDA Device Recall: MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multif
2019-04-03
Class II — The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
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FDA Device Recall: Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usa
2019-04-03
Class II — The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
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FDA Device Recall: MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Prod
2019-04-03
Class II — The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
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FDA Device Recall: URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The P
2019-04-03
Class II — The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
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FDA Device Recall: PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.
2019-02-27
Class II — Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby us...
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FDA Device Recall: PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.
2019-02-27
Class II — Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby us...
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FDA Device Recall: MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 P
2018-02-14
Class I — Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery ...
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FDA Device Recall: HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (
2017-04-05
Class I — HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
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ny_corps
1 records
NY Corp: PHILIPS NORTH AMERICA LLC
2017-05-18
FOREIGN LIMITED LIABILITY COMPANY | County: Albany | Jurisdiction: Delaware
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USASpending
29 records
Federal Award: PHILIPS NORTH AMERICA LLC — $1,133,900
2026-05-28
MODALITY: XR CATH LAB STATION: VAMC ST LOUIS, MO PURCHASE ORDER: 36A79726N0463, 657B60006 REQUIREMENT: ADMINISTRATIVE CORRECTIONS
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,877,298
2026-05-26
MODALITY: XR RF PURCHASE ORDER: 570B50011/36A79726N0443 STATION: VAMC FRESNO CA REQUIREMENT: SEP FY25 EQ CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,018,301
2026-04-16
MODALITY: XR-US REQUISITION: 621B50002 STATION: MOUNTAIN HOME VA MEDICAL CENTER REQUIREMENT: ULTRASOUND SYSTEM
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Federal Award: PHILIPS NORTH AMERICA LLC — $3,063,923
2026-04-13
MODALITY:XR US PO# 580B50070 STATION:HOUSTON, TX REQ: SEP FY25 EQ CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,029,523
2026-01-21
MODALITY: XR CATH LAB STATION: VAMC SALEM, VA PURCHASE ORDER: 36A79726N0178, 658B59002, 658B59007 REQUIREMENT: ADMINISTRATIVE CORRECTIONS
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,029,029
2025-11-05
PO: EQ 621B40008 TKY 621B40009 VAMC: MOUNTAIN HOME, TN MODALITY: XR-CT
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,163,777
2025-09-24
MODALITY: XR CATH LAB PURCHASE ORDER: 589B53003 STATION: VAMC COLUMBIA, MO REQUIREMENT: MARCH FY25 EQ CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,099,671
2024-09-19
MODALITY: RF SYSTEMS-HYBRID OR PURCHASE ORDER: 537B38032/537B38036 STATION: JESSE BROWN VAMC REQUIREMENT: SEP FY2023 CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $6,524,514
2024-08-01
PHILIPS IMAGING ANNUAL MAINTENANCE
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,168,999
2024-07-16
XR CATH LAB, 548-B30024, WEST PALM BEACH, FL, CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,979,387
2024-06-18
MODALITY: XR HYBRID STATION: VAMC LOUISVILLE, KY PURCHASE ORDER: 36A79724N0449, 603B44013 REQUIREMENT: ADMINISTRATIVE CORRECTIONS
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,638,122
2024-05-09
XR CATH LAB IR 580B30049 VAMC HOUSTON, TX SEP FY23 CONSOLIDATION
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,242,114
2024-05-01
HOSPITAL PHILIPS IMAGING EQUIPMENT SERVICE CONTRACT
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,675,832
2024-04-01
NAC TASK ORDER - PHILIPS IMAGING PMI SERVICES - BASE+1.5
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,901,520
2024-02-20
PURCHASE ORDER: 646B32004 MODALITY: XR EP LAB LOCATION:VAMC PITTSBURGH, PA REQUIREMENT: AZURION.7 C20 FLEXARM CATALYST
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,716,044
2024-01-17
PURCHASE ORDER: 646B32001 MODALITY: XR CATH LAB LOCATION: PITTSBURGH, PA REQUIREMENTS: NEW TO PHILIPS AZURIO
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,380,383
2023-06-01
MODALITY: XR US PURCHASE ORDER: 689B21024 STATION: VAMC WEST HAVEN CT REQUIREMENT: UPGRADE FOLLOW-ON ACTION FOLLOWING COMPETITIVE INITIAL ACTION
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Federal Award: PHILIPS NORTH AMERICA LLC — $2,618,215
2023-03-01
PHILIPS IMAGING EQUIPMENT MAINTENANCE
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Federal Award: PHILIPS NORTH AMERICA LLC — $3,063,055
2023-01-04
MODALITY: XR CT PURCHASE ORDER: 648B22537 STATION: VAMC PORTLAND OR
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Federal Award: PHILIPS NORTH AMERICA LLC — $1,408,201
2022-11-01
PHILIPS ALLURA XPER AND INGENUITY CT SERVICE PLAN
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Federal Award: PHILIPS NORTH AMERICA LLC — $4,560,867
2022-08-07
PREVENTATIVE MAINTENANCE OF PHILIPS RADIOLOGY EQUIPMENT
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Federal Award: PHILIPS NORTH AMERICA LLC — $3,056,731
2021-10-01
PHILIPS HTME PMI SERVICES - BASE YEAR
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Federal Award: PHILIPS NORTH AMERICA LLC — $6,970,338
2020-11-01
SERVICING PHILIPS EQUIPMENT
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Federal Award: PHILIPS NORTH AMERICA LLC — $68,167,100
2020-05-08
THIS SYSTEM WOULD BE USED AND INTEGRATED WITHIN ROUTINE CARE FOR BURNS AND TRAUMATIC INJURIES, BUT WOULD ALSO HAVE THE POTENTIAL TO BE OF USE IN DETECTION VIRAL PNEUMONIA OF COVID
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Federal Contractor: PHILIPS NORTH AMERICA LLC
Total awards: $175,149,524 | UEI: T41NB3MDAPZ6 | DUNS: 079503890
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Federal Contractor: PHILIPS NORTH AMERICA LLC
Total awards: $175,149,524 | UEI: T41NB3MDAPZ6 | DUNS: 079503890
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