Device product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Z-0222-2026
Product summary
- Event
- Event 97668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 UNITS
- Official record key
device-enforcement:Z-0222-2026
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)06971576832040; Serial Number: F00002, F00015
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.