uDR 596i Digital Medical X-Ray Imaging System — Class II medical device recall Z-2521-2020
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-07-15, distributed nationwide. Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exa
| Recall number | Z-2521-2020 |
|---|---|
| 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 | 2020-02-27 |
| Classified | 2020-07-06 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 06971576833023 |
| Serial numbers | 270012, 270013, 270014, 270015, 270016, 270017 |
| Model numbers | 596I |
Product
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
Reason for recall
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more 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-2521-2020. 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.