Device recall
Z-3048-2011: Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc…
FDA device recall · Class II · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-3048-2011 |
|---|---|
| Recall event | 59568 |
| Product | Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. |
| Product code | MHX |
| Recalling firm | Draeger Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2012 |
| 510(k) numbers | K070566 |
| FEI number | 2510954 |
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