Device recall
Z-1162-2021: WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG…
FDA device recall · Class II · Nihon Kohden America Inc
Key facts
| Recall number (Z-number) | Z-1162-2021 |
|---|---|
| Recall event | 87264 |
| Product | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI |
| Product code | DRG |
| Recalling firm | Nihon Kohden America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K071058 |
| FEI number | 2080783 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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