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U.S. Department of Health and Human Services

Class 1 Device Recall Philips Respironics Trilogy 100, Trilogy 200, Trilogy 202

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  Class 1 Device Recall Philips Respironics Trilogy 100, Trilogy 200, Trilogy 202 see related information
Date Initiated by Firm February 11, 2014
Date Posting Updated March 06, 2014
Recall Status1 Terminated 3 on April 17, 2015
Recall Number Z-1143-2014
Recall Event ID 67550
510(K)Number K083526  K093416  K093905  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Trilogy Ventilators
The Respironics Trilogy 100 system provides continuous or intermittent ventilator 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 device is 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. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is 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. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Code Information Model (s), Catelogue, or Code Numbers were identified as: 1040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International

1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447; TV114011448; TV114011449, TV11401144A; TV11401144B; TV11401144C; TV11401144D; TV11401144E;, TV114011450; TV114011451; TV11401145B; TV11401145C; TV11401145D;, TV11401145F; TV114011460; TV114011461; TV114011462; TV114011464; , TV114012326; TV114012364;TV1140120A9; TV114012323; TV11401212C;, TV11401230F; TV11401235A; TV11401235C; TV114012370TV114012371, TV114012372; TV114012376; TV114012415; TV114012465; TV21401150C;, TV214011510; TV11401153D; TV11401213E; TV21401150F;TV114012165;, TV11401133A;TV114012318; TV114012433; TV11401223A; TV11401223E;, TV114012170; TV114011722; TV1140120B2;TV114012416; TV114012235;, TV114012148; TV114011550; TV1140120BB; TV114012469; TV114012459;, TV114012732;TV21401150A; TV11401130C; TV11401236D; TV114011455 ;, TV114011465; TV114012239;TV11401223B; TV11401224D;TV114011336, TV11401133B;TV21401150E;TV214011511;TV214011513;TV214011515;, TV214011516;TV214011519;TV21401151B;TV21401151F;TV21401210B, TV214012117;TV214012119;TV21401211A;TV21401211D;TV214012122;, TV114011712;TV114011458; TV114012133;TV114012361;, TV114012429, TV11401245B, TV114011724, TV114011727, TV114011740, TV214011512, TV21401210C, TV214012111, TV214012120, TV214012121, TV21401240D, TV114012333, TV11401233E, TV114012349, TV11401234C, TV114012422, TV11401243B, TV11401245F, TV11401231C, TV114012355, TV114012137, TV11401233C, TV1140120DB, TV114012453, TV114011635, TV114011752, TV11401134F, TV114011741, TV114011757, TV114012095, TV1140120CD, TV1140120E3, TV11401215B, TV114012130, TV114012134, TV114012343, TV114012347, TV114012462, TV114012473, TV114011554, TV114011711, TV114011719, TV114011723, TV114011725, TV114012259, TV014011405, TV014011503, TV014011504, TV21401210D, TV21401210F, TV214012114, TV214012116, TV11401207D, TV11401207F, TV114012085, TV11401208C, TV1140120A6, TV114011311, TV1140120C1, TV114012146, TV1140120E2, TV11401174E, TV114011754, TV1140120DA, TV11401233A, TV114012342, TV11401234B, TV11401241D, TV114012441, TV114012456, TV114012458, TV11401245A, TV11401245C, TV11401245D, TV014012302, TV014012404, TV014012204, TV014012206, TV014012207, TV014012208, TV014012402, TV014012405, TV014012406, TV014012407, TV014012408, TV014011601, TV014011607, TV21401151D, TV214011522, TV114011335, TV114012313, TV11401236C, TV114011744, TV114012090, TV11401209C, TV11401209F, TV114012098, TV11401230C, TV114012377, TV11401213B, TV11401214A, TV114012154, TV11401245E, TV11401230B, TV114012414, TV114012417, TV014011401, TV014011406, TV11401214D, TV11401246D, TV114012418, TV11401241C, TV11312282C, TV11401130F, TV11401146A, TV11401146C, TV11401146F, TV114011523, TV114011524, TV11401152A, TV11401152D, TV114011530, TV114011536, TV114011538, TV11401155C, TV11401170F, TV114011717, TV11401172C, TV1140120DC, TV114012160, TV114012163, TV11401216A, TV11401216B, TV114012240, TV114012446, TV11401246E, TV1140120D4, TV1140120D5, TV114012155, TV114012157, TV114012423, TV114012132, TV11401241E, TV114012432, TV11401212E, TV114012312, TV11401231D, TV114012351, TV11401235D, TV114012468, TV11401246F, TV114012470, TV114012472, TV11401241A, TV11401242A, TV1140120D0, TV11401224E, TV114012233, TV114012234, TV114012237, TV11401223F, TV11401224C, TV114012250, TV114012255, TV114012256, TV11401225B, TV114011746, TV114012322, TV11401154F, TV11401231A, TV114012330, TV114011317, TV11401152C, TV114011540, TV114011546, TV11401154A, TV11401154E, TV114011551, TV114011555, TV114011562, TV11401170D, TV114011718, TV11401172B, TV114011745, TV114011760, TV21401151A, TV21401151C, TV1140120D9, TV114012162, TV114012238, TV114012242, TV11401224B, TV114012358, TV11401161A, TV11401161F, TV114011623, TV11401162E, TV11401162F;

Recalling Firm/
Manufacturer
Phillips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Customer Support
724-733-0200
Manufacturer Reason
for Recall
Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.
FDA Determined
Cause 2
Component design/selection
Action Philips sent an Urgent - Medical Device Recall letter on February 11, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the Notice with all members of their staff who need to be aware of the contents of the communication. For further information or support concerning the issue, customers were instructed to contact Philips Respironics at 877-387-3311. For questions regarding this recall call 724-733-0200.
Quantity in Commerce 572
Distribution Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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