Device recall
Z-0009-2014: GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or…
FDA device recall · Class I · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0009-2014 |
|---|---|
| Recall event | 66381 |
| Product | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. |
| Product code | BSZ |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 1, 2015 |
| 510(k) numbers | K110213, K112722, K123125 |
| FEI number | 2126677 |
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