A software glitch has prompted the recall of a Hamilton Medical AG ventilator, and the recall is serious enough that FDA has designated it as Class I.
Customers reported that the display screen on the Hamilton-G5 ventilator equipped with software versions V2.40 and V2.41 could freeze, and that they could no longer operate the device, according to the FDA’s announcement of the Class I designation.
FDA listed 248 ventilators in commerce.
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