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U.S. Department of Health and Human Services

Class 1 Device Recall Respironics Trilogy 100, 200, and 202 Ventilators

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 Class 1 Recall
Respironics Trilogy 100, 200, and 202 Ventilators
see related information
Date Posted July 23, 2012
Recall Status1 Terminated on November 01, 2012
Recall Number Z-2024-2012
Recall Event ID 62393
Premarket Notification
510(K) Numbers
K083526  K093416  K093905 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
Code Information Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
Recalling Firm/
Manufacturer
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville, Pennsylvania 15668-8517
For Additional Information Contact Customer Service
877-387-3311
Manufacturer Reason
for Recall
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Respironics, Inc. began contacting its affected US customers by phone beginning on Friday, April 27, 2012, and requested that they quarantine any affected devices within their possession and that they retrieve any devices with patients and quarantine those as well. Replacement devices were to be provided to all affected customers. For questions customers should call 724-387-7651. For questions regarding this recall call 877-387-3311..
Quantity in Commerce 173
Distribution Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.
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