Z-1003-2026 Class II Ongoing
FDA device recall Z-1003-2026 was initiated by Philips Healthcare (Suzhou) Co., Ltd. on December 3, 2025 and is designated Class II. Reason for recall: Potential for incomplete scan due to unstable connection inside of floating sensor. The recall status is ongoing. Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 35
Product Description
Philips Incisive CT
Reason for Recall
Potential for incomplete scan due to unstable connection inside of floating sensor.
Distribution Pattern
U.S. and U.S. territories