Device recall
Z-0281-2012: Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0281-2012 |
|---|---|
| Recall event | 60269 |
| Product | Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). |
| Product code | MHX |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2013 |
| 510(k) numbers | K070566 |
| FEI number | 2517967 |
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