Drug recall
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor…
FDA recall event 85196 · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Event ID | 85196 |
|---|---|
| Recall numbers | Z-2521-2020 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 27, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | May 28, 2021 |
| 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: