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

Medical DevicesSource: FDA (device) · Date: 2025-10-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
UIH Technologies LLC
Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Reason / hazard
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: OUS:
Recall initiated
2025-09-12
Code info
UDI: (01)06971576831104/ Serial Numbers: 863001, 863002
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Houston
State
TX
Country
United States
Event id
97668
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