Recall Z-1003-2026

Philips Healthcare (Suzhou) Co., Ltd. · initiated December 3, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Philips Incisive CT

Codes / lots: N/A

Reason for recall

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

FDA-determined cause: Radiation Control for Health and Safety Act

Action taken

Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install a hardware solution that will change the method of connection for the rear handle floating sensor. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-109 or FCO72800843.

Details

Recall number
Z-1003-2026
Initiated
December 3, 2025
Posted by FDA
January 8, 2026
Product code
JAK – System, X-Ray, Tomography, Computed
Quantity
35
Distribution
U.S. and U.S. territories
Recalling firm
Philips Healthcare (Suzhou) Co., Ltd., Suzhou, Pingjiang

Official FDA recall record