FDAnews Device Daily Bulletin

MAQUET Medical updated its voluntary recall information for the C20, C30 and C40 FLOW-i anesthesia systems after the FDA declared them Class I recalls. The devices, manufactured between May 2010 and December 2011, have encountered software malfunctions associated with the MAN/AUTO switch, used for changing between manual and automatic ventilation modes. MAQUET originally issued a recall in February of this year.
The GMP Letter