Device product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Z-0221-2026
Product summary
- Event
- Event 97668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0221-2026
Official wording
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information: UDI: (01)06971576831104/ Serial Numbers: 863001, 863002
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.