The FDA said GE had found that the ventilator's two vaporizers could deliver an anesthetic agent simultaneously, causing low blood pressure, irregular breathing and a drop in heart rate.
The recall of certain Aestiva/5 7900 ventilators, which started in April 2012, was classified a Class I recall - the most serious type of recall.
The Aestiva/5 7900 ventilator was approved by the U.S. Food and Drug Administration as an anesthesia machine in April 2000.