Datex-Ohmeda, Inc. — Class II: Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda, Inc. initiated a Class II recall for the Aisys CS2 anesthesia system due to electronic gas mixer assemblies that may automatically transition to Alternate O2 control. This transition interrupts anesthetic agent delivery and requires clinician intervention to prevent a decrease in anesthetic effect.
This recall affects Datex-Ohmeda, Inc. and healthcare facilities utilizing the Aisys CS2 with Et Control (Part Number 1011-9000-000), specifically impacting clinical anesthesia teams and biomedical engineering departments responsible for device maintenance.
The automatic transition to Alternate O2, while maintaining ventilation, introduces a risk of unintended patient awareness if clinicians do not promptly respond to alarms. From a regulatory perspective, this suggests a potential reliability issue with the electronic gas mixer components, requiring affected firms to evaluate their CAPA processes and user training regarding fail-safe modes.
Verify the presence of affected Aisys CS2 units in clinical inventory. Ensure anesthesia providers are aware of the audible and visual alarms associated with Alternate O2 control and the necessity of immediate manual intervention to restore anesthetic delivery. QA teams should monitor for failure patterns in electronic gas mixer assemblies.
Class II. 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. Firm: Datex-Ohmeda, Inc. (Madison WI United States). Status: Ongoing.
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