Device recall
Z-3192-2026: Et Control, Software option for anesthesia gas machine to achieve and maintain…
FDA device recall · Class II · Datex-Ohmeda, Inc.
Key facts
| Recall number (Z-number) | Z-3192-2026 |
|---|---|
| Recall event | 99649 |
| Product | Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665 |
| Product code | BSZ |
| Recalling firm | Datex-Ohmeda, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172045 |
| FEI number | 2112667 |
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