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Medical Device

Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

Recall date: 2026-09-23 · Source: FDA_DEVICE
Brand / Firm
Datex-Ohmeda, Inc.
Product
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Reason for recall
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.
Units affected
140 units
Description
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
View official recall notice →