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Browse Device Recalls

685 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 685 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 685 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2018 Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imag... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Reson... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonanc... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 19, 2018 Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... A software update is being issued to correct multiple issues identified in the previous software ... Class II Philips Medical Systems (Cleveland) Inc
Dec 3, 2018 Ingenia Elition S, Ingenia Elition X During automatic tabletop movement, pressing and holding the Stop Table button may lead to an u... Class II Philips Medical Systems Nederlands
Nov 30, 2018 Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Philips has discovered through customer complaints and internal testing an intermittent electroni... Class II Philips Medical Systems Nederlands
Nov 7, 2018 Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stati... kV/mA lockin not functioning as specified which may result in the patient receiving an increased ... Class II Philips Medical Systems Gmbh, DMC
Oct 18, 2018 Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray sys... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomogra... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray syst... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Sep 19, 2018 Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ... Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af... Class II Philips Medical Systems Gmbh, DMC
Sep 4, 2018 Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... Class II Philips Medical Systems (Cleveland) Inc
Jul 3, 2018 Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems in... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jul 3, 2018 Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems i... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jul 3, 2018 Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray system... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jun 27, 2018 DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 CombiDiagnost R90 (Stitching Patient Support) 709030 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 (Stitching Patient Support) 712225 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC

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.