Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control
- Recalling company
- Datex-Ohmeda, Inc.
- Product
- Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 30, 2026
- Reported
- Sep 23, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 7 units
- Lot / codes
- Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Company location
- Madison, WI
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3191-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3191-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.