Datex-Ohmeda Aisys CS2 anesthesia system recalled for gas mixer failure risk
What this means
Certain Datex-Ohmeda Aisys CS2 anesthesia systems can unexpectedly switch to a backup oxygen-only mode, stopping anesthetic agent delivery. The system triggers alarms when this occurs, but if clinicians do not respond quickly, patients may not receive adequate anesthesia.
- If you operate or maintain an Aisys CS2 system, contact Datex-Ohmeda to verify whether your unit's serial number is affected.
- Review the device alert and follow manufacturer guidance on inspection, testing, or repair of the gas mixer assembly.
- Ensure clinical staff are aware of this potential issue and trained to respond to alarms and manually restore anesthetic delivery if needed.
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-3190-2026More Datex-Ohmeda recalls
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