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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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| Oct 30, 2013 | Easy Diagnost Eleva Universal Fluoroscopic applications | The delivered application software was an outdated version to the model of equipment.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 |
| Jan 21, 2013 | Ingenuity TF PET/CT. Diagnostic imaging system | The system may not default to the same gating trigger with which the data were acquired. This cou... | Class II | Philips Medical Systems (Cleveland) 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 20, 2012 | Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emis... | Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 19, 2012 | Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray... | The four screws that secure the patient table top to the carrier became loose, which caused the t... | Class II | Philips Medical Systems (Cleveland) 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 |
| Oct 24, 2012 | Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 5, 2012 | Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), ... | Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection softwa... | Class II | Philips Medical Systems (Cleveland), Inc. |
| Sep 28, 2012 | Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... | Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 28, 2012 | Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... | Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 18, 2012 | Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips... | The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 11, 2012 | Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... | Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 31, 2012 | The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i... | Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 28, 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... | Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... | Class III | Philips Medical Systems (Cleveland) Inc |
| Aug 24, 2012 | MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT S... | On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 21, 2012 | Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ... | A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 8, 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 3, 2012 | The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ra... | The patient support may move in an unintended manner if the foot switch cover becomes damaged and... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 26, 2012 | Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model numbe... | Philips determined that it is important to clarify information in the Owner's Manual and keep cus... | Class II | Philips Medical Systems North America Co. Phi... |
| Jul 26, 2012 | Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured b... | Philips determined that it is important to clarify information in the Owner's Manual and keep cus... | Class II | Philips Medical Systems North America Co. Phi... |
| Jul 18, 2012 | The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... | 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 2, 2012 | Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomog... | Philips Healthcare was notified that several of the sixteen bolts securing the brackets which sup... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 23, 2012 | Intellispace Portal software. Intellispace Portal is a multimodality thin ... | Philips is issuing a software update to the Intellispace Portal systems to address a number of no... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 23, 2012 | IntelliSpace Portal software and Extended Brillance Workspace software In... | The Intellispace Portal software and Extended Brillance Workspace software may have significantly... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 22, 2012 | Intellispace Portal software Product Usage: Intellispace Portal is a mult... | In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using ... | 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.