Device recall
Z-3080-2024: GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant…
FDA device recall · Class II · Wipro GE Healthcare Private Ltd.
Key facts
| Recall number (Z-number) | Z-3080-2024 |
|---|---|
| Recall event | 95216 |
| Product | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external… |
| Product code | FMT |
| Recalling firm | Wipro GE Healthcare Private Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201628 |
| FEI number | 3007734888 |
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