Z-1003-2026 Class II Ongoing
FDA device recall Z-1003-2026 was initiated by Philips Healthcare (Suzhou) Co., Ltd. on Dec 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
- Jan 14, 2026
- Initiation Date
- Dec 3, 2025
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1003-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026