Datex-Ohmeda, Inc.: Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Hazard
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 alar…
Details
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. Distribution: Worldwide - US Nationwide distribution.. Recall #Z-3191-2026, initiated 20260730. Voluntary: Firm initiated.
Products affected
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Recall status
Ongoing
Reference: FDA Z-3191-2026 · Issued September 23, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.