Medical device recalls Moderate risk

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

Recall date
September 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0217-2026
FDA classification
Class II
Brand / firm
UIH Technologies LLC
Sold / distributed
US: OUS:

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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