Medium risk Drugs & MedicationsClass II

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
Read the official notice

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