Browse Device Recalls

421 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 421 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 421 FDA device recalls.

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DateProductReasonClassFirm
Mar 12, 2024 Intera 0.5T Standard, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 5300, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Evolution Upgrade 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Initial, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T R11, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Conversion, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera CV, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0TX for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 7700, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Enterprise 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva XR, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
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

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.