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
Nov 12, 2021 Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 wi... (1)Start-up problem: Intermittently at start-up of the system, the communication of the control u... Class II Philips North America Llc
Nov 12, 2021 BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisi... Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... Class II Philips North America Llc
Oct 29, 2021 Wireless Footswtich used with the following Philips Allura Xper and Azurion I... Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure Class II Philips North America Llc
Oct 21, 2021 ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... Class II Philips North America Llc
Oct 21, 2021 CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... Class II Philips North America Llc
Sep 24, 2021 Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... Class II Philips North America Llc
Aug 13, 2021 The Allura Xper series is intended for use on human patients to perform: "Va... Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... Class II Philips North America Llc
Aug 13, 2021 The Azurion series (within the limits of the used Operation Room table) are i... Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... Class II Philips North America Llc
Aug 13, 2021 The Allura Xper series is intended for use on human patients to perform: "Vas... Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... Class II Philips North America Llc
Aug 11, 2021 SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for u... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated f... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Jul 30, 2021 Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for u... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicate... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use ... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 30, 2021 Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for... Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... Class II Philips North America Llc
Jul 16, 2021 Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 Y... Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy... Class II Philips North America LLC
Jul 15, 2021 (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Prod... The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magne... Class II Philips North America
Jun 8, 2021 Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-r... When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iC... When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728332 IQon Spectral CT-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728333 Spectral CT 7500 -Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc

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.