Browse Device Recalls
124 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 124 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 124 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 5, 2015 | Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 3, 2015 | Philips Healthcare Allure BiPlane Series: Model 722013 Allura X... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper cardio systems Model : 722123 Product Usage: T... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper vascular system Model : 722124 Product Usage: ... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Nov 6, 2014 | CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direc... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPA... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- CO... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- C... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- CO... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COM... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, D... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPA... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 5, 2014 | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Aug 8, 2014 | Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system | Philips had discovered through a field service testing where a device failed to comply with a Fe... | Class II | Philips Medical Systems, Inc. |
| Jul 24, 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image... | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... | Class II | Philips Healthcare Informatics, Inc. |
| May 5, 2014 | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50... | When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error ca... | Class II | Philips Healthcare Informatics, Inc. |
| Jan 13, 2014 | InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V... | Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an ina... | Class II | Philips Healthcare |
| Dec 19, 2013 | Single and Dual use Emission Computer Tomography gamma cameras (BrightView XC... | Three problems were reported to the firm: When positioning for a relative 180 degree non circu... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 9, 2013 | Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips... | Patient images exhibited ring artifacts. | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 5, 2013 | GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare Sys... | The TF Big Bore patient table experienced mechanical binding during horizontal table motion resul... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 4, 2013 | Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brillianc... | Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 14, 2013 | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... | Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... | Class II | Philips Healthcare Informatics, Inc. |
| Aug 8, 2013 | Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-... | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... | Class II | Philips Healthcare Inc. |
| Jul 8, 2013 | Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.... | IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several m... | Class II | Philips Healthcare Inc. |
| Jul 5, 2013 | Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40,... | The patient support may move in an unintended manner if the footswitch cover impinges on the foot... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 19, 2013 | Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... | The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... | Class II | Philips Healthcare Inc. |
| Jun 11, 2013 | Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ra... | The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard... | Class II | Philips Healthcare Inc. |
| Apr 15, 2013 | Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, I... | Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core,... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2013 | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. | Class II | Philips Healthcare Inc. |
| Mar 12, 2013 | Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Wat... | Philips Healthcare received a report from the field stating when they viewed the CTDIVol informat... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 5, 2013 | Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Se... | If a customer creates customized trend scales in the trend review tile and the iX or primary serv... | Class II | Philips Healthcare Inc. |
| Jan 28, 2013 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The He... | Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... | Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table ... | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Uni... | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Nu... | An inspection shows several IATDs (Installation Acceptance Test could not be located or different... | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... | Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation A... | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032... | An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) recor... | Class II | Philips Healthcare Inc. |
| Jan 14, 2013 | Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 ... | VS2+ screen may lock up and stop monitoring during patient use | Class II | Philips Healthcare Inc. |
| Dec 20, 2012 | Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and ... | Philips Healthcare received reports from the field stating the patient table on a system had an u... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 13, 2012 | Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70... | Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the... | Class II | Philips Healthcare Inc. |
| Dec 3, 2012 | Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: B... | Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0x... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 28, 2012 | Mobile Diagnostic X-Ray System with Digital Panel | When the operator moves an image to another view then the electronic marker might be placed at th... | Class II | Philips Healthcare Inc. |
| Nov 9, 2012 | Philips IntelliVue Information Center/Client and Philips IntelliVue Informati... | Internal audio cable may have diminished retention force due to damaged contacts, which could lea... | Class II | Philips Healthcare 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.