FDA Enforcement
Class II
Ongoing
Philips Incisive CT
Recall: Z-1003-2026
·
Reported January 14, 2026
Enforcement
- Recall Number
- Z-1003-2026
- Event ID
- 98238
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Voluntary / Mandated
- FDA Mandated
- Report Date
- January 14, 2026
- Initiation Date
- December 3, 2025
- Classification Date
- January 8, 2026
- Address
- Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, N/A, China
Description
Philips Incisive CT
Reason
Potential for incomplete scan due to unstable connection inside of floating sensor.
Distribution
U.S. and U.S. territories
Quantity
35