Datex-Ohmeda anesthesia gas machines recalled for interrupted anesthetic agent delivery
What this means
Certain Datex-Ohmeda anesthesia delivery systems with electronic gas mixer assemblies can unexpectedly switch to a backup oxygen-only mode, which stops anesthetic agent delivery and requires immediate clinician action. If not addressed quickly, patients may receive less anesthesia than intended during surgery.
- If you operate or maintain these systems, check the serial number list against your equipment inventory.
- Contact Datex-Ohmeda immediately for instructions on software updates or replacement parts.
- Do not use affected machines until the issue is corrected.
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-3192-2026More Datex-Ohmeda recalls
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