'This could cause serious adverse health consequences, including hypoventilation and death,' the FDA statement reads.
The U.S. Food and Drug Administration has ordered a software recall for a type of ventilator, for fear of 'serious injuries or death.'The ventilators—the Philips Respironics, Inc. Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal—have been assigned a Class I recall, which is the most serious type of recall that the FDA has.
The Phillips Trilogy ventilators are controlled by a microprocessor that operates the blower for breathing support. They are used in medical, home, and non-emergency transport.According to the FDA recall, the latest software version of the devices may cause the device to show a 'battery depleted' or 'loss of power' alarm despite still having power, which may then cause the ventilator to stop ventilating altogether during the alarms if it is operating only on battery power.
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