Z-2024-2012 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- April 27, 2012
- Termination Date
- November 1, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173
Product 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.
Reason for Recall
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Distribution Pattern
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.
Code Information
Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.