← FDA ENFORCEMENT
Z-0222-2026Class 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
2 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. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

Code / lot info

UDI: (01)06971576832040; Serial Number: F00002, F00015

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 →