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Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ve

FDA device recall Z-2024-2012 · posted 2012-07-23 · Terminated

Recall details

Recalling firm
Respironics, Inc.
Reason for recall
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Action taken
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..
Root cause
Component design/selection
Status
Terminated
Product code
CBK
Quantity affected
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, J
Date initiated
2012-04-27
Date posted
2012-07-23
Date terminated
2012-11-01
Location
Murrysville, PA

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Related 510(k) clearances

RecordFirmDate
TRILOGY 202 VENTILATOR (K093905)Respironics, Inc.2010-05-12
TRILOGY 200 VENTILATOR (K093416)Respironics, Inc.2010-01-29
TRILOGY 100 VENTILATOR (K083526)Respironics Inc., Sleep & Home Respiratory Group2009-03-13