Device recall
Z-1526-2008: GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model #…
FDA device recall · Class II · Datex - Ohmeda, Inc
Key facts
| Recall number (Z-number) | Z-1526-2008 |
|---|---|
| Recall event | 44927 |
| Product | GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to… |
| Product code | CBK |
| Recalling firm | Datex - Ohmeda, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2012 |
| 510(k) numbers | K062710 |
| FEI number | 2183066 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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