Device recall
Z-1181-2021: Anesthesia gas-machine - Product Usage: intended for use in administering…
FDA device recall · Class II · Getinge Group Logistics America, LLC
Key facts
| Recall number (Z-number) | Z-1181-2021 |
|---|---|
| Recall event | 87301 |
| Product | Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe. |
| Product code | BSZ |
| Recalling firm | Getinge Group Logistics America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2023 |
| 510(k) numbers | K191027 |
| FEI number | 3025504317 |
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