The Recall Desk
HighFDA (Devices)·Z-0219-2026·Announced 2025-10-29

[pending] Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD

Pending LLM rewrite. Source: FDA_DEVICE Z-0219-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Manufacturer
UIH Technologies LLC

Distribution

Distribution scope not specified by the agency.