The US Food and Drug Administration (FDA) has issued a [removed]Class 1 recall [/removed]of Trilogy 100 Ventilators, produced by Respironics Inc, due to a manufacturing issue that can stop the device from delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. A failure to respond, the FDA warns, could result in the potential harm or death of a ventilator-dependent patient.
The Respironics Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of pediatric patients, weighing at least 11 pounds, through adult patients who require mechanical ventilation. The ventilators are used in hospitals, nursing homes, other health care settings, and in the home.
According to the FDA, Respironics notified its US distributors, providers, sales personnel, and customers of the recall by telephone on October 11, 2011. The company will continue to work with affected customers to arrange for the return and repair of all recalled ventilators.
Source: US Food and Drug Administration