The recall was issued for the C20, C30, and C40 FLOW-i Anesthesia Systems because if the MAN/AUTO switch was not in either an “on” or an “off” position but left in an in-between position for more than five seconds, an alarm may have been generated that prevents the system from switching ventilation modes, according to a Food and Drug Administration (FDA) Press Release.
The FDA classified this recall as a Class I, which is its most serious and involves a situation where there is a reasonable probability that use or exposure to a product will cause serious adverse health consequences or death.
In February 2012, the company initiated a voluntary worldwide field correction of the C20, C30 and C40 systems.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.