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U.S. Department of Health and Human Services

Medical Devices

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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:

TV111021835TV111031420TV111032905TV111032935
TV111022832TV111031462TV111032906TV111032938
TV111030853TV111031554TV111032909TV111032939
TV111030932TV111032809TV111032912TV111032940
TV111030947TV111032811TV111032913TV111033001
TV111030976TV111032812TV111032914TV111033004
TV111030978TV111032822TV111032920TV111033005
TV111031001TV111032827TV111032923TV111033006
TV111031011TV111032829TV111032924TV111033009
TV111031037TV111032830TV111032925TV111033010
TV111031045TV111032832TV111032926TV111033016
TV111031403TV111032833TV111032929TV111033018
TV111031413TV111032901TV111032934TV111033019

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.

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