Philips North America
45 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips North America and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-04FDA-DeviceClass IISmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IISmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIUpgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIMR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIIngenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIEvolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceClass IIEvolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-01-28FDA-DeviceClass IIPatient Information Center iX; Software Version Number: 4.5.0
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
- 2025-12-17FDA-DeviceClass IIAzurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
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 FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
- 2025-10-22FDA-DeviceClass IICardiac Workstation 7000; Model Number: 860441;
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
- 2025-10-22FDA-DeviceClass IICardiac Workstation 5000; Model Number: 860439;
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
- 2025-08-06FDA-DeviceClass IIUpgrade to MR 7700 Model Number (REF): 782130;
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.
- 2025-08-06FDA-DeviceClass IISmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
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.
- 2025-08-06FDA-DeviceClass IISmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
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.
- 2025-08-06FDA-DeviceClass IISmartPath to dStream for 3.0T Model Number (REF): 782145;
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.
- 2025-08-06FDA-DeviceClass IIMR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
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.
- 2025-08-06FDA-DeviceClass IIMR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
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.
- 2025-08-06FDA-DeviceClass IIIntera 3.0T Quasar Dual Model Number (REF): 781150;
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.
- 2025-08-06FDA-DeviceClass IIIngenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
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.
- 2025-08-06FDA-DeviceClass IIIngenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
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.
- 2025-08-06FDA-DeviceClass IIIngenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
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.
- 2025-08-06FDA-DeviceClass IIIngenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
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.
- 2025-08-06FDA-DeviceClass IIIngenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
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.
- 2025-08-06FDA-DeviceClass IIIngenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
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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