Drug recall
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
FDA recall event 90104 · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Event ID | 90104 |
|---|---|
| Recall numbers | Z-1075-2022 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Product type | Devices |
| Products | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 30, 2019 |
| Report date | May 18, 2022 |
| Termination date | May 17, 2022 |
| City | Shanghai |
| Country | China |
| FEI number | 3011015597 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: