Computed Tomography X-ray System — Class II medical device recall Z-2641-2020
Ongoing recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-07-29, distributed in TX. Two issues were identified with the computed tomography x-ray system including a service function which may ca
| Recall number | Z-2641-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, N/A, China |
| Recall initiated | 2020-05-23 |
| Classified | 2020-07-17 |
| Reported by FDA | 2020-07-29 |
| Distributed | TX |
| Quantity | 3 |
| UPC / GTIN / UDI-DI | 06971576831036 |
| Serial numbers | 353020, 353021, 353023 |
| Model numbers | 550 |
Product
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
Reason for recall
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
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-2641-2020. 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.