GE Healthcare (NYSE:GE) landed Class I status for its Aestiva/5 7900 ventilator recall, a category the FDA reserves for the most serious issues "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
GE recalled the devices, which deliver continuous breathing support for patients who require mechanical ventilation during surgical procedures, over concerns that its 2 vaporizers may inappropriately deliver agents simultaneously.
That could result in over-delivery if both vaporizers contain the same agent or in simultaneous delivery of more than one agent, according to the recall notice.
"Unrecognized overdose with simultaneous inhaled anesthetics is manifested by hypotension (low blood pressure), arrhythmias (irregular breathing), and bradycardia (low heart rate) that, if persists and remains unrecognized, may lead to circulatory shock," the agency noted. "This ventilator may cause serious adverse health consequences, including death."
Maquet issues Class I recall over software issue in Flow-i anesthesia system
Maquet Medical is offering customers with its Flow-i anesthesia system a free software upgrade to patch an issue that resulting in technical alarms that were generated when the device wasn’t fully switched "on" or "off" but was left in between the 2 positions.
The alert was dubbed a Class I recall by the FDA for a potential for "serious adverse health consequences, including death," as a result of the defect.