MAQUET Medical Systems announced Friday that the U.S. Food and Drug Administration has classified its voluntary recall of certain anesthesia machines as a Class I recall.
MAQUET, a subsidiary of the public Swedish firm Getinge Group, instituted a voluntary recall of the C20, C30 and C40 FLOW-i Anesthesia Systems in February because of a software malfunction associated with the MAN/AUTO switch used for changing between manual and automatic ventilation modes, according to a news release. The recall only affects products sold between May 2010and December 2011. The Flow-i C30 model was sold in the U.S. while the C20 and C40 models were sold overseas.
According to one FDA adverse event report on its MAUDE databasethat occurred Nov. 1, the C30 model generated a technical error code showing that the anesthesia machine was delivering lower oxygen than the level at which it was set.
A Class I recall is designated to be the most serious of all recall notifications by the FDA because it describes “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
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