Z-0217-2026 Class II Ongoing

Recalled by UIH Technologies LLC — Houston, TX

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