Browse Device Recalls

313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 313 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 313 FDA device recalls.

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DateProductReasonClassFirm
Aug 5, 2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... Due to a software issue, there is a potential image error of the Region of Interest for expansion... Class II Philips Medical Systems (Cleveland) Inc
Jul 17, 2025 Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculati... Class II Philips Medical Systems (Cleveland) Inc
Aug 30, 2022 Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. When computing a radiation dose in the system, the exported dose information is incorrect when th... Class II Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 IQon Spectral CT Model # 728332, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Vereos PET/CT Model # 882446, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity Core Model # 728321, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity CT, Model # 728326, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT, Model # 728306, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Brilliance 64 Model # 728231, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 10, 2019 BrightView X , Model Number 882478 An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... Class II Philips Medical Systems (Cleveland) Inc
Jun 10, 2019 BrightView SPECT, Model Number 882480 An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... Class II Philips Medical Systems (Cleveland) Inc
Jun 10, 2019 BrightView XCT , Model Number 882482 An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... Class II Philips Medical Systems (Cleveland) Inc
Jun 3, 2019 Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomograp... The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cov... Class II Philips Medical Systems (Cleveland) Inc
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
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 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
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
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
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

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.