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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Sample couch parameter files are supplied with monaco release 3.100 and later. the user can then access these files from the treatment couch library.By clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the "save as treatment couch" to enter a unique name for the modified couch parameter file., when sample couch parameter files are edited, the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, the modified couch densities in these samples will be overwrittem with the default value of 1.000.
  • Acción
    Manufacturer to issue advice regarding use


  • Modelo / Serial
    Model: , Affected: , Software version: 3.100 and later
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source