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.
Enforcement
- Recall Number
- Z-2024-2012
- Event ID
- 62393
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Respironics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 1, 2012
- Initiation Date
- April 27, 2012
- Classification Date
- July 23, 2012
- Termination Date
- November 1, 2012
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States
Description
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.
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
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.
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