← FDA ENFORCEMENT
Z-0217-2026Class II

UIH Technologies LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
UIH Technologies LLC
Product type
Device
Status
Ongoing
Report date
2025-10-29
Distribution
US: OUS:
Firm state
TX
Product quantity
8 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Product description

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

Code / lot info

Serial Numbers: ; UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →