Digitial Medica X-ray Imagining System — Class II medical device recall Z-1160-2021
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2021-03-10, distributed nationwide. There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This c
| Recall number | Z-1160-2021 |
|---|---|
| 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 | 2021-01-25 |
| Classified | 2021-03-02 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2022-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 06971576833023 |
| Serial numbers | 270012, 270013, 270014, 270015, 270016, 270017 |
| Model numbers | 596I, CE0123 |
Product
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used 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. Not for mammography.
Reason for recall
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
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-1160-2021. 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.