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
Jun 27, 2018 DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 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 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 Upgrades (Stitching Patient Support) 712083 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 (Stitching Patient Support) 712025 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) 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 Release 3 (Stitching Patient Support) 712025 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 High Performance (Stitching Patient Support) 712027 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 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 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 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 EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 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 Single Detector (Stitching Patient Support) 712020 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) 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 BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
May 21, 2018 Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01... The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw ... Class II Philips Medical Systems (Cleveland) Inc
May 1, 2018 OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. ... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands
May 1, 2018 OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands
Mar 30, 2018 Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 7282... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 30, 2018 Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 72... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 30, 2018 Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 7282... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity Core128/Elite China 728324 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity TF PET/CT 882442 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity Core128 728323 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Philips Ingenuity Core 728321 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Brilliance Big Bore Radiology 728244 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 26, 2018 MultiDim Eleva 708032 As a multifunctional universal imaging application... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional univers... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnost Eleva 708036 As a multifunctional universal imaging applicat... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 708033 URODiagnost As a multifunctional universal imaging application syst... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Feb 21, 2018 Brilliance 64 with 4.1.7 XX026 software version model number 728231 Produc... Surview scan with tube current lower than 30 mA is unable to be initialized. Class II Philips Medical Systems (Cleveland) Inc
Feb 15, 2018 Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an int... Following a period of inactivity, the mass storage device may cause the acquisition console to be... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Produc... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray syst... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray syste... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Jan 11, 2018 IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Comput... 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues inc... Class II Philips Medical Systems (Cleveland) Inc
Jan 3, 2018 Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244... Software issues including: Software errors that may result in Extended Field of View check messa... Class II Philips Medical Systems (Cleveland) Inc
Jan 3, 2018 Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 ... Software issues including: Software errors that may result in Extended Field of View check messa... Class II Philips Medical Systems (Cleveland) Inc

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.