Events

Retiro De Equipo (Recall) de RaySearch RayStation Radiation therapy treatment planning system

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por RaySearch Laboratories AB.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18523
  • Fecha de inicio del evento
    2015-05-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    When vmat control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate. such plans will never be generated by raystation and imported plans with this wide gantry angle spacing will normally not be possible to use for dose calculation in raystation. however, if the imported plan is assigned to a vmat enabled machine model with minimum dose rate = 0.00 mu/min and minimum gantry speed = 0.0 degrees/s, it is possible to calculate dose., , depending on the individual plan, local dose inaccuracy in some regions close to the patient surface may range from under a percent to several percent of dose max. the deviation increases with the gantry angle spacing and with the number of affected control points. the problem will mainly occur in the region furthest away from the isocenter.
  • Acción
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB