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The recall notice, issued May 10, 2010, affects anesthesia systems distributed between October 9,

2009, and October 29, 2009. Customers received a GE Healthcare "Urgent Medical Device

Correction" letter dated March 12, 2010. The recall includes specific lot and serial numbers of Aisys

model number 1011-9000-000 and Avance model number 1009-9002-000.

More information is available on the FDA's Web site.

The anesthesia systems provide general inhalation anesthesia and ventilation support and are

intended for volume or pressure control ventilation in a healthcare setting.

According to the FDA, class 1 recalls are the most serious type of recall and involve situations in

which there is a reasonable probability that use of these products will cause serious adverse health

consequences or death.

 

 

 

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