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…
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- Philips Healthcare
- Product
- Incisive CT, software version 5.0
- Classification
- Class II
- Units
- US Nationwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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
- 2026-09-02
USPhilips 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 →- 2026-01-14
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Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
- 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 → - 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
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,…
- 2022-03-30
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- 2021-12-01
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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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