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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.