Philips Healthcare recalls

8 official recalls and safety alerts involving Philips Healthcare since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Philips Healthcare or the relevant agency.

1. 2026-09-02
2. US
   Drugs & medicalClass II

   Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

   Potential of failing to trigger clinical scan during Bolus Tracking.

   FDA · DevicePhilips Healthcare (Suzhou) Co., Ltd.U.S. Nationwide and U.S. Territories distribution.Official notice →
3. 2026-01-14
4. US
   Drugs & medicalClass II

   Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT

   Potential for incomplete scan due to unstable connection inside of floating sensor.

   FDA · DevicePhilips Healthcare (Suzhou) Co., Ltd.U.S. and U.S. territoriesOfficial notice →
5. 2024-01-17
6. US
   Drugs & medicalClass II

   Philips Healthcare (Suzhou) Co., Ltd. recalls 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 or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion…

   FDA · DevicePhilips Healthcare (Suzhou) Co., Ltd.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
7. 2023-10-11
8. US
   Drugs & medicalClass II

   Philips Healthcare recalls Incisive CT, software version 5.0

   Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted…

   FDA · DevicePhilips HealthcareUS Nationwide DistributionOfficial notice →
9. 2022-04-13
10. US
    Drugs & medicalClass II

    Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

    Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system,…

    FDA · DevicePhilips HealthcareUS Nationwide distribution.Official notice →
11. 2022-03-30
12. US
    Drugs & medicalClass II

    Philips Healthcare recalls 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 Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…

    FDA · DevicePhilips HealthcareUS Nationwide DistributionOfficial notice →
13. 2021-12-01
14. US
    Drugs & medicalClass II

    Philips Healthcare recalls 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 Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and…

    FDA · DevicePhilips HealthcareUS Nationwide DistributionOfficial notice →
15. US
    Drugs & medicalClass II

    Philips Healthcare recalls 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 product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting…

    FDA · DevicePhilips HealthcareUS Nationwide distributionOfficial notice →