Device recall
Z-0784-2007: GE Healthcare Engstrom Carestation Critical Care Ventilator with the High…
FDA device recall · Class II · Datex - Ohmeda, Inc
Key facts
| Recall number (Z-number) | Z-0784-2007 |
|---|---|
| Recall event | 37105 |
| Product | GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI… |
| Product code | CBK |
| Recalling firm | Datex - Ohmeda, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 16, 2008 |
| 510(k) numbers | K060862 |
| 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