Device recall
Z-1549-2014: Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1549-2014 |
|---|---|
| Recall event | 68067 |
| Product | Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin… |
| Product code | FMT |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2016 |
| 510(k) numbers | K122267, K123309 |
| 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