Maquet Medical Systems USA FLOW-i Anesthesia System: Class I Recall - Device Field Correction
MedSun: Newsletter #75, August 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of the Maquet Medical Systems USA FLOW-i Anesthesia System (software). A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in between the two positions. Use of this product may cause serious adverse health consequences, including death.

Additional Information:

FDA MedWatch Safety Alert. Maquet Medical Systems USA FLOW-i Anesthesia System: Class I Recall - Device Field Correction. July 11, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311471.htm


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