Digital Medical X-ray Imaging System — Class II medical device recall Z-1075-2022
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2022-05-18, distributed nationwide. X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and
| Recall number | Z-1075-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, N/A, China |
| Recall initiated | 2019-07-30 |
| Classified | 2022-05-12 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2022-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 06971576833023 |
| Serial numbers | 270012, 270013, 270014, 270015 |
| Model numbers | 592H, 596I |
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Reason for recall
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
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-1075-2022. 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.