medical Class I Updated 2024-10-30

Datex-Ohmeda, Inc. recalls Avance CS2 and Avance CS2 Pro. These anesthesia gas machines

Recalled Product

Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 00840682102322. Model Numbers: 1009-9050-000, 1011-9050-000, 1009-9002-000, 1009-9212-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.
View official government recall

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