FDA Device recall Z-1075-2022
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- FDA Device
- Class II
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h by Shanghai United Imaging Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1075-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-30 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Reason
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.
Identifiers
| code_info | DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2022%22
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