FDAFDA · Alimentos y medicamentos·N.º oficial Z-2024-2012
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.
Publicado el 1 de agosto de 2012 · Inicio del retiro: 27 de abril de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Respironics, Inc.
- Distribuidor
- 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.
- Lote
- Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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