Device recall
Z-1829-2008: GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1829-2008 |
|---|---|
| Recall event | 48080 |
| Product | GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic… |
| Product code | CBK |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2012 |
| 510(k) numbers | K062710 |
| FEI number | 3004526608 |
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