FDA recall, , Moderate risk
Philips Incisive CT with Software V4.5&V5.0
Philips Incisive CT may fail to trigger a clinical scan during Bolus Tracking.
Summary by Recall Canary from the FDA notice
What happened
Philips Healthcare (Suzhou) Co., Ltd., located in Suzhou, China, recalled its Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144, due to a potential of failing to trigger clinical scan during Bolus Tracking. The recall began on June 26, 2026, and was added to the FDA's Enforcement Report on August 21, 2026. The product was distributed nationwide in the U.S. and U.S. Territories.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- UDI-DI
- 00884838085015
- 00884838105508
Recall details
- Company began the recall
- Sold in
U.S. Nationwide and U.S. Territories distribution.
- Company
- Philips Healthcare (Suzhou) Co., Ltd.Suzhou, China
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99511
- Recall number
- Z-2988-2026
All recalls from Philips Healthcare (Suzhou) Co., Ltd.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
