Device recall
Z-2284-2010: Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor…
FDA device recall · Class II · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2284-2010 |
|---|---|
| Recall event | 55870 |
| Product | Infinity Delta/Gamma X XL Patient Monitor. 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 | Jul 30, 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