Philips North America Llc
195 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips North America Llc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-24FDA-DeviceClass IIGYROSCAN ACS-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIEvolution Upgrade 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIEnterprise 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva XR, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 3.0TX for PET, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 3.0T for PET, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 1.5T Initial, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 1.5T Conversion, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceClass IIAchieva 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-01-24FDA-DeviceClass IISpectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Multiple software issues that affect device functionality.
- 2023-12-27FDA-DeviceClass IIThe device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
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.
- 2023-12-20FDA-DeviceClass IPanorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
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 system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.
- 2023-11-29FDA-DeviceClass IISmartPath to dStream for 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIIntera 1.5T Power/Pulsar
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIIntera 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIIngenia 1.5T CX
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIAchieva 1.5T Initial System
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIAchieva 1.5T Conversion
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceClass IIAchieva 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-22FDA-DeviceClass IIBrilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
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 fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
- 2023-11-22FDA-DeviceClass IIBrilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
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 fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
- 2023-11-22FDA-DeviceClass IIBig Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
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 fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
- 2023-11-15FDA-DeviceClass IIProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIEasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
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