Recall archive / FDA device enforcement
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only — FDA record Z-0218-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 12, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
- Reason
- Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Classification
- Class II
- Recalling firm
- UIH Technologies LLC
- Quantity
- 22 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0218-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: OUS:
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Sep 12, 2025
- Center classification date
- Oct 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.