Device recall
Z-0081-2025: Aisys. This anesthesia gas machine is intended to provide general inhalation…
FDA device recall · Class I · Datex-Ohmeda, Inc.
Key facts
| Recall number (Z-number) | Z-0081-2025 |
|---|---|
| Recall event | 95045 |
| Product | Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia. |
| Product code | BSZ |
| Recalling firm | Datex-Ohmeda, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K172045 |
| FEI number | 2112667 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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