Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

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DateProductReasonClassFirm
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.
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 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 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 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.
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.
Oct 30, 2012 Philips Digital Diagnost Stationary radiographic system When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
Oct 30, 2012 Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in ... Class II Philips Healthcare Inc.
Oct 25, 2012 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
Sep 12, 2012 Philips Digital Diagnost with patient carriage Model: 712050 with serial nu... Hook does not securely hold the footplate in vertical position, causing the footplate to disengag... Class II Philips Healthcare Inc.
Sep 11, 2012 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... Class II Philips Healthcare Inc.
Sep 6, 2012 Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and ... Class II Philips Healthcare Inc.
Aug 15, 2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wa... Class II Philips Healthcare Inc.
Aug 14, 2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (... Class II Philips Healthcare Inc.
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 11, 2012 Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could ... Class II Philips Healthcare Inc.
Jul 11, 2012 Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 ... When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always st... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddl... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class II Philips Healthcare Inc.
Jun 14, 2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Class II Philips Healthcare Inc.
May 22, 2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirro... Class II Philips Healthcare Inc.
May 21, 2012 Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 70... MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement Class II Philips Healthcare Inc.
May 11, 2012 Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured... Class II Philips Healthcare Inc.
Oct 19, 2011 Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribu... When the system is switched off or when the tube arm is parked in the down position (X-ray genera... Class II Philips Healthcare Inc.
Apr 5, 2010 Philips Healthcare Computed Tomography X-Ray System. These devices are who... Philips Healthcare discovered the customer was performing CTDI measurements for facility accredi... 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.