FDA Enforcement
Class II
Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Recall: Z-0219-2026
·
Reported October 29, 2025
Enforcement
- Recall Number
- Z-0219-2026
- Event ID
- 97668
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- UIH Technologies LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 29, 2025
- Initiation Date
- September 12, 2025
- Classification Date
- October 21, 2025
- Address
- 9380 Kirby Dr, Houston, TX, 77054-2515, United States
Description
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Reason
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code Info
UDI: (01)06971576831043/Serial Number: 600229 600232 600271 600282 604001 604002 604003 604004 604005 604006 604008
Distribution
US: OUS:
Quantity
11 units