Device recall
Z-2235-2020: Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-2235-2020 |
|---|---|
| Recall event | 85643 |
| Product | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. |
| Product code | FMZ |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2024 |
| 510(k) numbers | K020543, K101788 |
| 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