Browse Device Recalls
685 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 685 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 685 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 4, 2013 | ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distribu... | The recalling firm determined that visual inspections of the fork joints behind the detector that... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 4, 2013 | Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model ... | The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisiti... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 30, 2013 | Easy Diagnost Eleva Universal Fluoroscopic applications | The delivered application software was an outdated version to the model of equipment. | Class II | Philips Medical Systems, Inc. |
| Oct 23, 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... | It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the ti... | Class II | Philips Medical Systems, Inc. |
| Oct 17, 2013 | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagn... | A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and... | Class II | Philips Medical Systems North America Inc. |
| Oct 14, 2013 | Philips Multi Diagnost Eleva with FlatDetector | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... | Class II | Philips Medical Systems, Inc. |
| Oct 14, 2013 | Philips Multi Diagnost Eleva II | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... | Class II | Philips Medical Systems, Inc. |
| Oct 11, 2013 | Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Br... | If the couch, with the footrest extension attached, is positioned where the table travel is withi... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 3, 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... | Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 30, 2013 | Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brillia... | There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 16, 2013 | Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... | Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 7, 2013 | Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1... | There is a potential for water to collect in the vent pipe elbow in the magnet venting system. W... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 22, 2013 | MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-... | A pinch point at the end of the table top can cause injury. | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 16, 2013 | Brilliance iCT and Brilliance iCT SP These systems are intended to produce... | An artifact that resembles thrombus may appear on the image. | Class II | Philips Medical Systems (Cleveland) 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 7, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A2... | Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monit... | Class II | Philips Medical Systems, Inc. |
| Apr 25, 2013 | BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medic... | Philips has received one report from the field that there was an unexpected motion of the detecto... | Class II | Philips Medical Systems (Cleveland) 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 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... | Class II | Philips Medical Systems, Inc. |
| Mar 21, 2013 | Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanner... | If the operator selects a patient name from the worklist using the mouse and then selects a diffe... | Class II | Philips Medical Systems (Cleveland) 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 |
| Feb 15, 2013 | Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brillian... | This field change order is being released to update software and customer release notes to the af... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 12, 2013 | Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel... | Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ... | 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.