Recall Z-1003-2026
Philips Healthcare (Suzhou) Co., Ltd. · initiated December 3, 2025
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