Browse Device Recalls
725 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 725 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 725 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 7, 2012 | The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended ... | Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems cur... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 1, 2011 | The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... | During a Field Test (a customer external evaluation period), the customer detected a problem in t... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 7, 2011 | Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, ... | The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a re... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 3, 2011 | Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... | Multiple software defects which could impact the performance or reliability of the system. These... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 1, 2008 | GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile install... | The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 9, 2007 | No packaging. The device is a computed tomography scanner. Intended to ... | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in te... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2006 | Brilliance CT (computed tomography) scanners, Big Bore configuration, Model n... | Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization appli... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 27, 2005 | Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... | The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... | 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.