Device recall
Z-1472-2023: Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse…
FDA device recall · Class II · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1472-2023 |
|---|---|
| Recall event | 91938 |
| Product | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network, |
| Product code | MHX |
| Recalling firm | Draeger Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200859 |
| 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