Drugs & medicalClass II

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

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

Read the official notice →
Date
2026-01-14
Country
United States
Brand
Philips Healthcare
Product
Philips Incisive CT
Classification
Class II
Units
U.S. and U.S. territories
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Philips Healthcare recalls

  1. 2026-09-02
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    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. 2024-01-17
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    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 →
  5. 2023-10-11
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    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 →
  7. 2022-04-13
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    Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

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  9. 2022-03-30
  10. US
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    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 →
  11. 2021-12-01
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    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…

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