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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 Posted March 06, 2014
Recall Status1 Terminated 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
724-733-0200
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 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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