FDA assigns Class I status to GE ventilator/anesthesia machine recalls

The FDA slapped GE Healthcare's ($GE) recall of a number of ventilator and anesthesia machines with a Class I status--its most serious designation. GE itself announced in mid-October that it had initiated a voluntary field corrective action for the products--the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines--due to a potential safety issue involving unresponsive buttons on the display for each product. The concern is the malfunction could lead to treatment delays that could harm or kill patients. The FDA said customers could potentially circumvent the problem by pressing the key again or accessing the menu function through the control wheel. GE Healthcare, meanwhile, is following up with all customers and said it would fix the affected systems free of charge. Recall

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