Device recall
Z-2357-2026: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator…
FDA device recall · Class I · Datex-Ohmeda Inc
Key facts
| Recall number (Z-number) | Z-2357-2026 |
|---|---|
| Recall event | 99036 |
| Product | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance |
| Product code | BTM |
| Recalling firm | Datex-Ohmeda Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K070247 |
| FEI number | 3036470679 |
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