Washington, DC: The Food and Drug Administration (FDA) has notified healthcare professionals of the Class 1 recall of Respironics, Inc. Trilogy 100 Ventilators due to a manufacturing issue, specifically that the ventilator can stop delivering therapy to the 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 and other health care settings, and in the home.
Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient. See the Recall Notice for a list of affected serial numbers.
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