Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Published September 23, 2026 · Recall initiated: July 30, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datex-Ohmeda, Inc.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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