Browse Device Recalls

313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 313 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 313 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2014 MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can ... "The orientation of images is displayed incorrectly. When operator chooses gantry on the ri... Class II Philips Medical Systems (Cleveland) Inc
Sep 11, 2014 The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed... Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order tha... Class II Philips Medical Systems (Cleveland) 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
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
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 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 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
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 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 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 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
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
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
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

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.