Getinge Group Logistics America, LLC recalls Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire venti…

Recall date

January 29, 2021

Source

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

Recall number

Z-1181-2021

FDA classification

Class II

Brand / firm

Getinge Group Logistics America, LLC

Sold / distributed

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, WV.

Why it was recalled

Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.