Class II — Shanghai United Imaging Healthcare Co., Ltd.
| Recalling firm | Shanghai United Imaging Healthcare Co.,Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | uCT 760 System, Computed Tomography X-ray System |
| Quantity | 5 units |
| Distribution | Distributed to two customers. Both customers located in Houston, Texas. |
| Initiated | 2020-05-08 |
| Classified | 2020-07-06 |
| Terminated | 2022-01-20 |
| Recall number | Z-2522-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Shanghai United Imaging Healthcare Co., Ltd. (Z-2522-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85804/
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