Events

Retiro De Equipo (Recall) de Elekta Synergy, Base drive wheel assembly

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 Limited (England).

¿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
    14629
  • Fecha de inicio del evento
    2013-05-10
  • 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
    In a small number of digital accelerators, the gantry base wheel bolts have become loose and caused a malfunction. there have been a small number of digital accelerators where the joint between the drive gear and the gantry base drive wheel has become loose. this has lead to fatigue failure of the securing bolts.
  • Acción
    Product to be modified

Device

Elekta Synergy, Base drive wheel assembly
  • Modelo / Serial
    Model: , Affected: Serial numbers 105345 to 151764 inclusive with XVI
  • Manufacturer
    Elekta Limited (England)

Manufacturer

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