The FDA has issued a Class I recall for the Aestiva/5 7900 ventilator because of a risk of unrecognized overdosing that may be fatal during surgery.
The ventilator's two vaporizers may deliver therapy at the same time, which can result in an over-delivery of anesthetics. "Unrecognized overdose with simultaneous inhaled anesthetics is manifested by hypotension, arrhythmias, and bradycardia ... that may lead to circulatory shock," the FDA said in a statement.
The recall affects products with the serial numbers AMRP01031, AMRP00966, AMPR01030, AMRP00986, AMRP01033, AMRP00970, and AMRP00969. The affected products were manufactured on July 2, 2010.