FDAFDA · Alimentos y medicamentos·N.º oficial Z-2561-2019
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Publicado el 2 de octubre de 2019 · Inicio del retiro: 4 de septiembre de 2019
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Elekta Inc
- Distribuidor
- Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
- Lote
- UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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