Drug recall
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA recall event 97668 · Class II · UIH Technologies LLC
Key facts
| Event ID | 97668 |
|---|---|
| Recall numbers | Z-0217-2026, Z-0218-2026, Z-0219-2026, Z-0220-2026, Z-0221-2026, Z-0222-2026, Z-0223-2026, Z-0224-2026, Z-0225-2026 |
| Recalling firm | UIH Technologies LLC |
| Product type | Devices |
| Products | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only, Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only, Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only, Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only, Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only and 4 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
| Initiation date | Sep 12, 2025 |
| Report date | Oct 29, 2025 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3014809646 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: