Datex-Ohmeda, Inc. 2024-10-30 Health critical FDA
Health · FDA · Recall #FDA-Z-0083-2025
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general… Recall
Issued October 30, 2024 · Datex-Ohmeda, Inc.
In October 2024, Datex-Ohmeda, Inc. recalled the Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
What you should do
- 1 Stop using Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Datex-Ohmeda, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Datex-Ohmeda, Inc.
- Category
- Health
- Recall date
- October 30, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHA
- Recall number
- FDA-Z-0083-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Datex-Ohmeda, Inc. has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.