Z-0217-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Distribution Pattern
US: OUS:
Code Information
Serial Numbers: ; UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006