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.

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DateProductReasonClassFirm
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.