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
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
Dec 15, 2017 Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffi... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView X, Model #882478 Product Usage: BrightView and BrightView X a... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma came... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView Model 882480 Product Usage: BrightView and BrightView X are g... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 11, 2017 Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This d... A software issue causes PET reconstructions to fail intermittently. It was determined that recons... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Brilliance 64, (Code 728231) Intended to produce images of the head and bo... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Ingenuity Core, (Code 728321) Intended to produce images of the head and b... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Brilliance iCT Intended to produce images of the head and body by computer... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Ingenuity Core 128, (Code 728323) Intended to produce images of the head a... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare IQon Spectral CT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare Brilliance iCT SP computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare Brilliance iCT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 1, 2017 Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) ... One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to... Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity Core 128 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity CT computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity Core computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Brilliance 64 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Jul 11, 2017 Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tom... Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jul 11, 2017 Brilliance iCT - Model 728306 Computed Tomography X-ray systems Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: C... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usag... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Co... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Produ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Feb 24, 2017 BrightView SPECT model number 882480 BrightView and BrightView X are gamma c... The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... Class II Philips Medical Systems (Cleveland) Inc
Feb 24, 2017 BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c... The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... Class III Philips Medical Systems (Cleveland) Inc
Feb 24, 2017 BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma c... The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... Class II Philips Medical Systems (Cleveland) Inc
Feb 24, 2017 BrightView XCT model number 882482 BrightView and BrightView X are gamma cam... The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... Class II Philips Medical Systems (Cleveland) Inc
Feb 23, 2017 Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... Class II Philips Medical Systems (Cleveland) Inc
Feb 23, 2017 Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... Class II Philips Medical Systems (Cleveland) Inc
Jan 31, 2017 882478: BrightView X designed for single or dual detector nuclear imaging acc... Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... Class II Philips Medical Systems (Cleveland) Inc
Jan 31, 2017 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for singl... Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... Class II Philips Medical Systems (Cleveland) Inc
Jan 31, 2017 882480: BrightView designed for single or dual detector nuclear imaging accom... Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... Class II Philips Medical Systems (Cleveland) Inc
Dec 23, 2016 BrightView XCT The intended use listed in the English and localized language IFUs for BrightView XCT systems did... Class II Philips Medical Systems (Cleveland) Inc
Dec 23, 2016 Brilliance iCT During a retrospective review of production documentation it was observed that the M6 Rotor Count... Class II Philips Medical Systems (Cleveland) Inc
Dec 23, 2016 BrightView X upgraded to XCT 882454 The intended use listed in the English and localized language IFUs for BrightView XCT systems did... Class II Philips Medical Systems (Cleveland) Inc
Dec 16, 2016 IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... 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.