Device recall
Z-1635-2009: Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1635-2009 |
|---|---|
| Recall event | 50800 |
| Product | Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. |
| 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