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Open, Classified

Philips Incisive CT

FDA Recall Z-1003-2026 · Posted 2026-01-08

Recalling FirmPhilips Healthcare (Suzhou) Co., Ltd.
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2025-12-03
Product Quantity35

Reason for Recall

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and U.S. territories

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022-04-27K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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