FDAJanuary 29, 2021device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

getinge group logistics americagetingegetinge group

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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