Class II — Datex-Ohmeda, Inc.
| Recalling firm | Datex-Ohmeda, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect. |
| Product | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 |
| Quantity | 7 units |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2026-07-30 |
| Classified | 2026-09-16 |
| Recall number | Z-3191-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Datex-Ohmeda, Inc. (Z-3191-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99649/
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