Datex-Ohmeda Aisys CS2 anesthesia system recalled for anesthetic delivery interruption
What this means
Certain Datex-Ohmeda Aisys CS2 anesthesia systems with specific electronic gas mixer assemblies can automatically switch to a backup oxygen-only mode. When this happens, the delivery of anesthetic medication stops, and the system triggers alarms. A clinician must manually intervene to restore anesthetic delivery, or the patient may not receive adequate anesthesia.
- Check if your serial number matches the affected units: ANAS01357, ANAP00609, ANAQ00988, ANAS00586, ANAR00543, ANAP01088, ANAM00443.
- If your system is affected, contact Datex-Ohmeda, Inc. for guidance on the electronic gas mixer assembly.
- Follow your facility's procedures for equipment review and clinical safety protocols.
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-3191-2026More Datex-Ohmeda recalls
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