Device recall
Z-1634-2009: Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1634-2009 |
|---|---|
| Recall event | 50800 |
| Product | Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia. |
| Product code | BSZ |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2012 |
| 510(k) numbers | K042154, K050676 |
| 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