FDA Recall Open, Classified

Philips Incisive CT

Recall: Z-1003-2026 · Initiated December 3, 2025

Recall

Recall Number
Z-1003-2026
Event Number
98238
Firm
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No.
FEI Number
3009529630
Product Code
JAK
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
December 3, 2025
Posted
January 8, 2026
Address
258 Zhongyuan Road, Pingjiang Suzhou China

Description

Philips Incisive CT

Reason

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

Action

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.

Distribution

U.S. and U.S. territories

Quantity

35