Respironics, Inc. Trilogy 100 Ventilators
Recall Class: Class I
Date Recall Initiated: October 11, 2011
Product: Trilogy 100 ventilators manufactured from February 1, 2011 to April 30, 2011.
Use: 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.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall: Trilogy 100 ventilators are being recalled due to a manufacturing issue. This issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. In the event of a blower failure, the ventilator will stop delivering therapy and a high priority alarm will sound to alert the caregiver to immediately respond. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.
Public Contact: Affected customers with questions may contact Respironics Customer Service, toll-free, at: 1-877-387-3311.
FDA District: Philadelphia
Respironics notified its United States 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 or repair of all recalled ventilators.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
Adverse reactions and/or quality problems should also be reported to Respironics at 1-877-387-3311.