Computed Tomography X-Ray System — Class II medical device recall Z-0446-2021
Ongoing recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-11-18, distributed nationwide. A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP
| Recall number | Z-0446-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China |
| Recall initiated | 2020-08-05 |
| Classified | 2020-11-12 |
| Reported by FDA | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 06971576831036 |
| Serial numbers | 353020, 353021, 353023, 353045, 353049 |
| Model numbers | 550 |
Product
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended 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, vascular).
Reason for recall
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
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-0446-2021. 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.