FDA recall, , Moderate risk
Philips Incisive CT
Philips Incisive CT may have an incomplete scan due to an unstable connection inside the floating sensor.
Summary by Recall Canary from the FDA notice
What happened
Philips Healthcare (Suzhou) Co., Ltd., based in Suzhou, China, began a recall of the Philips Incisive CT on December 3, 2025, because of a potential for an incomplete scan due to an unstable connection inside of the floating sensor. The U.S. Food and Drug Administration added the recall to its Enforcement Report and classified it on January 8, 2026, with distribution in the United States 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?
Compare these details with yours, then check the recall notice to see which units are recalled.
Philips Incisive CT
Recall details
- Company began the recall
- Sold in
U.S. and U.S. territories
- 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
- 98238
- Recall number
- Z-1003-2026
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
In FDA's weekly enforcement report
Listed on Recall Canary
