GE Healthcare recalls some ventilators on safety issue
July 11 (Reuters) - 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 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.
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.
- Tweet this
- Share this
- Digg this