Device recall
Z-1012-2022: Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For…
FDA device recall · Class II · Draegar Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1012-2022 |
|---|---|
| Recall event | 89877 |
| Product | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices. |
| Product code | MHX |
| Recalling firm | Draegar Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130711 |
| FEI number | 3005783425 |
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