Device recall
Z-1471-2023: Draeger Infinity CentralStation (ICS), centralized monitoring of adult…
FDA device recall · Class II · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1471-2023 |
|---|---|
| Recall event | 91938 |
| Product | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower |
| Product code | MHX |
| Recalling firm | Draeger Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151860 |
| 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