Events

Retiro De Equipo (Recall) de Elekta Monaco Radiation 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 Elekta Inc.

¿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
    19289
  • Fecha de inicio del evento
    2015-10-21
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Causa
    Two identified issues:, 1- in version 5.10.01, the isodose control 100% isodose value was linked to the dose normalization value so users would always have a known normalization value linked to 100% when in relative mode. this however limits the user to only one defined value available above 100%. when the 100% isodose value is edited on the isodose control, the dose normalization is automatically updated. if the user does not notice this update and then rescales to a relative isoline and does not read the dose normalization value displayed on the rescale bar, the rescale could be other than intended., , 2-when the user optimizes, then changes the bolus assignment of the beams, and then selects "calculate" (not "optimize" again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect for the bolus assignment of the beams.
  • Acción
    Software to be upgraded

Device

Elekta Monaco Radiation Treatment Planning System
  • Modelo / Serial
    Model: , Affected: , Software version: 5.10 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NZMMDSA