Device recall
Z-1160-2021: Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01)…
FDA device recall · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1160-2021 |
|---|---|
| Recall event | 87289 |
| 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… |
| Product code | KPR |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2022 |
| 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