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UIH Technologies LLC: Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 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 550 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)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017
Product quantity
22 units
Voluntary mandated
Voluntary: Firm initiated
City
Houston
State
TX
Country
United States
Event id
97668
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