July 11 General Electric Co's healthcare
unit recalled some ventilators, starting in April, on concerns
that the device could deliver a potentially fatal overdose of
anesthesia to patients undergoing surgery, the U.S. Food and
Drug Administration said on Wednesday.
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
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.
Problems over the last couple of year with life-saving
devices such as all-metal hip implants from Johnson & Johnson
and defibrillators from St. Jude Medical Inc
have prompted the U.S. health regulator to propose a $550
million post-market surveillance system for medical devices.
Shares of GE were flat at $19.69 on Wednesday on the New
York Stock Exchange.