Device recall
Z-2227-2008: Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880…
FDA device recall · Class II · Datex Ohmeda, Inc. dba GE Healthcare
Key facts
| Recall number (Z-number) | Z-2227-2008 |
|---|---|
| Recall event | 48603 |
| Product | Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. |
| Product code | FMT |
| Recalling firm | Datex Ohmeda, Inc. dba GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2012 |
| 510(k) numbers | K070377 |
| FEI number | 1121732 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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