Device product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Z-0217-2026
Product summary
- Event
- Event 97668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0217-2026
Official wording
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information: Serial Numbers: ; UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006
Distribution pattern: US: OUS:
Derived failure modes
-
Unknown
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.