FDA Issues Class I Recall of Respironics Trilogy 100 Ventilators
The federal agency in charge of monitoring defective medical devices has issued its most serious type of recall for a breathing support ventilator used in hospitals, nursing homes, in-home health settings and other healthcare environments.
According to the Food and Drug Administration (FDA), the Philips Respironics Trilogy 100 ventilator, intended for use in pediatric and adult patients, could stop circulating air and other gas, which could lead to serious injury or death.
The agency has issued a class I recall covering 52 serial numbers that could have parts that move out of position, which should sound an alarm. Health officials said serious health problems or death could occur if the alarm is ignored.
Respironics has notified its U.S. customers, healthcare providers and sales personnel advising them to return or repair the recalled products.
Philips Respironics, which is a division of the Dutch conglomerate Koninklijke Philips Electronics NV, is the world’s largest manufacturer of medical devices for chronic breathing disorders.