Browse Device Recalls
124 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 124 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 124 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2025 | Philips Incisive CT | Potential for incomplete scan due to unstable connection inside of floating sensor. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Aug 2, 2023 | Incisive CT, software version 5.0 | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... | Class II | Philips Healthcare |
| Dec 23, 2022 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Feb 2, 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion... | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition doe... | Class II | Philips Healthcare |
| Sep 24, 2021 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This ... | Class II | Philips Healthcare |
| Sep 22, 2021 | ProxiDiagnost N90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | CombiDiagnost R90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| May 26, 2021 | Azurion systems with software release R2.0.x | In the Azurion system, the user can add a new study to a patient by selecting the option "Add Stu... | Class II | Philips Healthcare |
| Feb 24, 2021 | Philips CT systems are advanced continuous-rotation computed tomography syste... | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which ... | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Apr 19, 2019 | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be ... | Images may potentially become corrupt while using the system. | Class II | Philips Healthcare Informatics, Inc. |
| Dec 21, 2018 | DigitalDiagnost C50, Stationary X-ray System | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing... | Class II | Philips Healthcare |
| Jun 11, 2018 | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular im... | The first time an operator selects a new procedure type during a single examination,the shutter p... | Class II | Philips Healthcare |
| Jun 11, 2018 | UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging a... | The first time an operator selects a new procedure type during a single examination,the shutter p... | Class II | Philips Healthcare |
| Jun 11, 2018 | Centron Product Usage: Vascular,cardiovascular and neurovascular imagin... | The first time an operator selects a new procedure type during a single examination,the shutter p... | Class II | Philips Healthcare |
| Nov 8, 2017 | Philips Healthcare IQon Spectral CT computed tomography x-ray system | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 8, 2017 | Philips Healthcare Brilliance iCT SP computed tomography x-ray system | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 8, 2017 | Philips Healthcare Brilliance iCT computed tomography x-ray system | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 18, 2017 | Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These ... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These compu... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed The... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These comp... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These co... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Apr 1, 2016 | Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... | Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... | Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 15, 2016 | Philips Healthcare System X-ray Tomography Computed : | It was discovered the patient support tabletop may fail to move in the horizontal direction when... | Class II | Philips Electronics North America Corporation |
| Mar 15, 2016 | Philips Healthcare System X-ray Tomography Computed : | It was discovered the patient support tabletop may fail to move in the horizontal direction when... | Class II | Philips Electronics North America Corporation |
| Nov 25, 2015 | Philips Healthcare IntelliVue Info Center iX, A.0 866023 | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 25, 2015 | Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, P... | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 25, 2015 | Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Moni... | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 10, 2015 | Philips Healthcare DuraDiagnost stationary X-ray system | The detector may signal that it is ready for acquisition when it actually is not, resulting in f... | Class II | Philips Healthcare |
| Nov 10, 2015 | Philips Healthcare DigitalDiagnost stationary X-ray system | The detector may signal that it is ready for acquisition when it actually is not, resulting in f... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance iCT Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Jul 23, 2015 | Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems | Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruct... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 22, 2015 | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A ra... | If arm is not fastened securely it could fall down. | Class II | Philips Electronics North America Corporation |
| May 15, 2015 | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catal... | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or hi... | Class II | Philips Ultrasound, Inc. |
| Apr 14, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Feb 9, 2015 | Philips Healthcare DuraDiagnost X- Ray | The system is designed to emit a beep upon termination of an exposure. However, if the system ha... | Class II | Philips Medical Systems, Inc. |
| Feb 9, 2015 | Philips Healthcare DigitalDiagnost System X-Ray | The system is designed to emit a beep upon termination of an exposure. However, if the system ha... | Class II | Philips Medical Systems, 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.