Shanghai United Imaging Healthcare Co — Class II medical device recall Z-0224-2026
Ongoing recall by UIH Technologies LLC, reported 2025-10-29. Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference
| Recall number | Z-0224-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | UIH Technologies LLC, Houston, TX, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 06971576832033 |
| Serial numbers | 300072, 300082, 300098 |
| Model numbers | 780MD |
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Reason for recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0224-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.