Device recall
Z-2521-2020: uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use…
FDA device recall · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2521-2020 |
|---|---|
| Recall event | 85196 |
| 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. |
| Product code | KPR |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 28, 2021 |
| 510(k) numbers | K181413 |
| FEI number | 3011015597 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database