Events

Retiro De Equipo (Recall) de Elekta HexaPOD evo RT System, iGUIDE 2.0

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 Medical Intelligence Medizintechnik GmbH.

¿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
    16780
  • Fecha de inicio del evento
    2014-06-05
  • 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
    The iguide key allows you to treat patients without using the hexapod evo rt system. when you turn the iguide key to the off position:, · the external inhibit signal is overridden., · the iguide software closes any open fractions and logs off (login appears)., in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when you turn the iguide key back to the on position, it will not set the external inhibit signal or alert you if the position has changed (position guard is inactive).
  • Acción
    Software to be upgraded

Device

Elekta HexaPOD evo RT System, iGUIDE 2.0

Manufacturer

Medical Intelligence Medizintechnik GmbH
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NZMMDSA