Browse Device Recalls
440 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 440 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 440 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 12, 2024 | Achieva 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 1.5T S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Feb 28, 2024 | Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 28, 2024 | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 15, 2024 | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... | If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... | Class II | Philips North America Llc |
| Jan 3, 2024 | SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva XR. Model (REF) Numbers 781153, 781253. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 15, 2023 | BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 8824... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/... | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s ra... | Class II | Philips North America |
| Dec 15, 2023 | ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy... | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients rad... | Class II | Philips North America |
| Dec 15, 2023 | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 7, 2023 | Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste... | If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope... | Class II | Philips North America |
| Nov 30, 2023 | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Multiple software issues that affect device functionality. | Class II | Philips North America Llc |
| Nov 30, 2023 | BrightView XCT, Gamma Camera, Product Code 882482 | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... | Class II | Philips North America |
| Nov 30, 2023 | BrightView, Gamma Camera System, Product Code 882480. | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... | Class II | Philips North America |
| Nov 30, 2023 | BrightView X, Gamma Camera, Product Code 882478 | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... | Class II | Philips North America |
| Nov 28, 2023 | (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 | Push notifications may fail to send to the user under certain conditions. This could potentially ... | Class II | Philips North America |
| Nov 28, 2023 | (1) Patient Information Center iX, Model No. 866389 (2) Patient Information ... | Push notifications may fail to send to the user under certain conditions. This could potentially ... | Class II | Philips North America |
| Nov 17, 2023 | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7... | Firm was informed of an event in which the structural integrity of the MR system components faile... | Class I | Philips North America Llc |
| Oct 23, 2023 | Intera 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Intera 1.5T Power/Pulsar | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T Conversion | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T Initial System | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Ingenia 1.5T CX | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | SmartPath to dStream for 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 9, 2023 | Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... | Class II | Philips North America |
| Oct 9, 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... | Class II | Philips North America |
| Oct 4, 2023 | Integris-Allura IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Azurion IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.