The FDA has assigned its most serious designation to GE Healthcare's ($GE) recall of Aestiva/5 7900, warning that a flaw in the devices could lead to circulatory shock and death.
GE launched a recall of the devices in April, warning that the two vaporizers in the continuous-breathing-support machines may malfunction and deliver agents at the same time. That could lead to the over-delivery of inhaled anesthetics, which the FDA said could lead to low blood pressure, irregular breathing, low heart rate and circulatory shock.
GE warned physicians of the issue on April 10 and has begun corrective action, but the FDA tabbed the recall a Class I because of the risk of fatal overdose from the ventilator's malfunction.
The devices are used in hospitals and clinics to provide breathing support for patients undergoing surgery. The Aestiva/5 7900 has been on the market since 2000, but the affected models were manufactured in 2010, according to the FDA.
When last we heard from GE Healthcare, the company was taking a proactive approach to concerns about the effects of radiation exposure from its CT scanners, promising to work with hospitals to reduce radiation dosing by 50%.