FDAFDA · Alimentos y medicamentos·N.º oficial Z-0780-2014
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Publicado el 29 de enero de 2014 · Inicio del retiro: 25 de noviembre de 2013
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
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Elekta, Inc.
- Distribuidor
- Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
- Lote
- Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States