FDAHealthSeptember 12, 2025
UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
⚠️ Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
US: OUS:
What's affected?
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
- Brand
- UIH Technologies LLC
- Lot code
- 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
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 22 units.
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