Datex-Ohmeda, Inc. recalls Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati…

Recall date

July 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0081-2025

FDA classification

Class I

Brand / firm

Datex-Ohmeda, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, C…

Why it was recalled

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.