uCT 760 System — Class II medical device recall Z-2522-2020
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-07-15, distributed in TX. Two issues were identified with the computed tomography x-ray system including an intermittent issue which may
| Recall number | Z-2522-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China |
| Recall initiated | 2020-05-08 |
| Classified | 2020-07-06 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-01-20 |
| Distributed | TX |
| Quantity | 5 units |
| Serial numbers | 600229, 600230, 600232, 600271, 600282 |
| Model numbers | 760 |
Product
uCT 760 System, Computed Tomography X-ray System
Reason for recall
Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
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-2522-2020. 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.