Datex-Ohmeda Aisys anesthesia system recalled for anesthetic agent delivery interruption risk
What this means
Certain Datex-Ohmeda Aisys anesthesia systems may automatically switch to a backup oxygen-only mode, which stops anesthetic agent delivery to the patient. The system will alert staff with audible and visual alarms when this occurs. If staff do not quickly intervene, the patient may not receive adequate anesthesia during the procedure.
- Check if your system's serial number matches the affected list provided by the manufacturer.
- Contact Datex-Ohmeda for repair or replacement of the affected electronic gas mixer assembly.
- Until repaired, ensure clinical staff are briefed on the malfunction symptoms and required manual override procedures.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3189-2026More Datex-Ohmeda recalls
- FDA-Device2026-09-23Datex-Ohmeda Aisys CS2 anesthesia system recalled for gas mixer failure risk
- FDA-Device2026-09-23Datex-Ohmeda anesthesia gas machines recalled for interrupted anesthetic agent delivery
- FDA-Device2026-09-23Datex-Ohmeda Aisys CS2 anesthesia system recalled for anesthetic delivery interruption
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