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Medical Devices

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.

Serial Numbers:

TV111021835 TV111031420 TV111032905 TV111032935 TV111022832 TV111031462 TV111032906 TV111032938 TV111030853 TV111031554 TV111032909 TV111032939 TV111030932 TV111032809 TV111032912 TV111032940 TV111030947 TV111032811 TV111032913 TV111033001 TV111030976 TV111032812 TV111032914 TV111033004 TV111030978 TV111032822 TV111032920 TV111033005 TV111031001 TV111032827 TV111032923 TV111033006 TV111031011 TV111032829 TV111032924 TV111033009 TV111031037 TV111032830 TV111032925 TV111033010 TV111031045 TV111032832 TV111032926 TV111033016 TV111031403 TV111032833 TV111032929 TV111033018 TV111031413 TV111032901 TV111032934 TV111033019

Recalling Firm:

Respironics, Inc.
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

FDA Comments:

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.

Page Last Updated: 01/12/2015
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