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Browse Device Recalls

65 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 65 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 65 FDA device recalls.

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DateProductReasonClassFirm
Apr 23, 2015 Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in th... Class II Philips Medical Systems, Inc.
Feb 9, 2015 Philips Healthcare DuraDiagnost X- Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, Inc.
Feb 9, 2015 Philips Healthcare DigitalDiagnost System X-Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, 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.
Jan 23, 2015 Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode... Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installatio... Class II Philips Medical Systems, Inc.
Dec 23, 2014 HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ... MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b... Class II Philips Medical Systems, Inc.
Dec 19, 2014 Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i... Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification Class II Philips Medical Systems, Inc.
Nov 20, 2014 Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg... VCG battery ignited in a VCG unit when recharging. Class II Philips Medical Systems, Inc.
Nov 19, 2014 Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliV... Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneou... Class II Philips Medical Systems, Inc.
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor... Class II Philips Medical Systems, Inc.
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid... Class II Philips Medical Systems, Inc.
Nov 19, 2014 HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte... Class II Philips Medical Systems, Inc.
Oct 10, 2014 Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an... Mold on gel filled Gel-E and Squishon products Class I Philips Medical Systems, Inc.
Oct 3, 2014 Philips Avalon Monitors with software revision J.30.58: Model Product F... Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... Class II Philips Medical Systems, Inc.
Oct 3, 2014 Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo... Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... Class II Philips Medical Systems, Inc.
Sep 24, 2014 Foot Switches used with the following systems: Philips Allura Xper Systems; 7... Loss of key image functionality due to a bent pedal of the Footswitch. Class II Philips Medical Systems, Inc.
Sep 24, 2014 Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... Loss of key image functionality due to a bent pedal of the Footswitch. Class II Philips Medical Systems, Inc.
Aug 21, 2014 Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,... Class II Philips Medical Systems, Inc.
Aug 19, 2014 Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Mod... The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... Class II Philips Medical Systems, Inc.
Aug 19, 2014 Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Mo... The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... Class II Philips Medical Systems, 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.
Aug 7, 2014 Philips IntelliSpace ECG Management System, with software option C61 needed ... Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q... Class II Philips Medical Systems, Inc.
Jul 31, 2014 Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... It was discovered that a software defect may result in the scanner not terminating the CT scan a... Class II Philips Medical Systems, Inc.
Jul 8, 2014 Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... Class II Philips Medical Systems, Inc.
Jul 8, 2014 Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 1.5T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 1.5T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 6, 2014 Philips Medical System Allura Xper X-Ray Angiographic In certain circumstances, a software error can lead to a situation where the five minute fluorosc... Class II Philips Medical Systems, Inc.
May 22, 2014 IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I... IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume... Class II Philips Medical Systems, Inc.
May 15, 2014 Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T pro... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 15, 2014 Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T prod... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 5, 2014 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... In spine clinical workflows, cross reference lines may be used to determine the position of slice... Class II Philips Medical Systems, Inc.
Apr 8, 2014 Intended for both adult and pediatric patients for taking diagnostic radiogra... In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an un... Class II Philips Medical Systems, Inc.
Apr 4, 2014 Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor... The risk of battery failure increases with age, when a battery remains in use longer than 3 years... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m... Class II Philips Medical Systems, Inc.
Mar 31, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automati... A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the abili... Class II Philips Medical Systems, Inc.
Mar 17, 2014 Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50... The footboard of Patient support for stitching can be fixed in upper position. When the fix clam... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J... ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which co... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc... Class II Philips Medical Systems, 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.