Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent venti...
FDA Device Recall #Z-1143-2014 — Class I — February 11, 2014
Recall Summary
| Recall Number | Z-1143-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | February 11, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Phillips Respironics, Inc. |
| Location | Murrysville, PA |
| Product Type | Devices |
| Quantity | 572 |
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.
Lot / 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;
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.