Datex-Ohmeda, Inc. Recall
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Updated July 30, 2026
Datex-Ohmeda, Inc. is recalling 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 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.
Is the Datex-Ohmeda, Inc. recalled? Yes. This product was recalled by FDA on July 30, 2026. Details below.
What is recalled
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Am I affected
You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.
What to do right now
Voluntary: Firm initiated
The 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 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.
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-Z-3191-2026
- Classification
- Class II
- Recalled
- July 30, 2026
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