FDAFDA · Food and drugs·Recall number Z-0218-2026
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Published October 29, 2025 · Recall initiated: September 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- UIH Technologies LLC
- Distributor
- US: OUS:
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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