FDADecember 22, 2022device

Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

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

The hazard

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

What to do

FDA enforcement status: Ongoing

Brands named

getinge usa salesgetingegetinge usa

Recall history

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

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