Device recall
Z-1070-2014: GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe…
FDA device recall · Class I · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1070-2014 |
|---|---|
| Recall event | 67004 |
| Product | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary… |
| Product code | BTL |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 22, 2016 |
| 510(k) numbers | K070210 |
| FEI number | 2126677 |
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