MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System
Published: Jul 6, 2012
Maquet Critical Care AB and MAQUET Medical Systems USA has issued the following update regarding its voluntary worldwide field correction for its C20, C30 and C40 FLOW-i Anesthesia Systems. The recall was related to a software problem with the MAN/AUTO switch used for changing between manual and automatic ventilation modes. The corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall.
This action only affected FLOW-i Anesthesia Systems distributed between May 2010 and December 2011 and therefore, has no affect on the company's current product production, shipping or distribution processes.
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