Device recall
Z-1196-06: Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1196-06 |
|---|---|
| Recall event | 34631 |
| Product | Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management… |
| Product code | BSZ |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2007 |
| 510(k) numbers | K973985 |
| 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