Datex-Ohmeda Aisys Anesthesia Systems
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Datex-Ohmeda, Inc., of Madison, Wisconsin, began a recall on July 30, 2026, for Aisys Datex-Ohmeda anesthesia systems, Et Control software options, and Aisys CS2 systems with or without Et Control, due to automatic transition to Alternate O2 control, which delivers 100% O2 to the breathing system and initiates audible and visual alarms. The recall was added to the FDA's Enforcement Report on September 16, 2026, with nationwide distribution.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI and part code are listed under that product.
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- UDI-DI
- 00840682102292
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU)
- UDI-DI
- 801042711
- 801031045
- 801031926
- 801045423
- 801011743
- 801090568
- 801128677
- 801011276
- Part code
- 1011-8000-000-S
- 5700665
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- UDI-DI
- 00195278588128
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Event ID
- 99649
- Recall numbers
- Z-3189-2026 to Z-3192-2026
- Company
- Datex-Ohmeda, Inc.Madison, Wisconsin
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
