Telford, PA’s Dräger Medical warned customers that the alarm on more than 400 of its ventilators may inadvertently go off and cause the device to stop functioning. Dräger said that personal injury was not reported in any of those situations.
But the FDA still deemed the corrective action a Class I recall, which is reserved for situations in which “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
