Browse Device Recalls

708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 708 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 708 FDA device recalls.

Clear
DateProductReasonClassFirm
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 27, 2014 IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... The following software issues have been identified in the affected products. Problem 1: When reo... Class II Philips Medical Systems (Cleveland) 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 23, 2014 BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat... Flat Panel Display (FPD) failed to remain securely locked in the deployed position. Class II Philips Medical Systems (Cleveland) Inc
Jun 18, 2014 GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: ... When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to ... Class II Philips Medical Systems (Cleveland) 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.
Apr 1, 2014 Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT seri... A customer reported that the table top had become free floating. A Field Service Engineer (FSE) ... Class II Philips Medical Systems (Cleveland) 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 27, 2014 Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brillian... Block assembly-lock stop subframe of service latch was not manufactured to engineering specificat... Class II Philips Medical Systems (Cleveland) 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.
Mar 11, 2014 IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... Class II Philips Medical Systems (Cleveland) Inc
Mar 10, 2014 Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC V... Slippage of the radius drive belt in the relative 180 degree orientation of the superior position... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... Class II Philips Medical Systems (Cleveland) Inc
Feb 28, 2014 Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America Inc.
Feb 28, 2014 Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America 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.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A,... MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... Wireless Link may be unable to transmit data when configured for a specific data flow. Class II Philips Medical Systems, Inc.
Feb 14, 2014 Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Produc... Philips HeartStart XL may experience a power board failure causing failure to defibrillate Class II Philips Medical Systems, Inc.
Feb 11, 2014 Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Philips Medical Systems have recently determined that a software nonconformance can cause incorre... Class II Philips Medical Systems (Cleveland), Inc.
Feb 6, 2014 Philips HeartStart Home and OnSite (HS1) automated external defibrillators (A... Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) be... Class II Philips Medical Systems North America Inc.
Feb 6, 2014 Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... Class II Philips Medical Systems North America Inc.
Feb 4, 2014 Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M... HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing... Class II Philips Medical Systems, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
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 19, 2013 Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System ... During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio fr... Class II Philips Medical Systems (Cleveland) Inc
Dec 10, 2013 Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... Class II Philips Medical Systems, 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 Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 ... X-ray system C-arm casting may loosen and fall Class II Philips Medical Systems, 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

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.