Events

Retiro De Equipo (Recall) de Elekta Xio RTP 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
    15779
  • Fecha de inicio del evento
    2013-12-02
  • 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
    When computing the effective depth (with bolus) to the weight point, xio could use the bolus density for a particular segment of the weight fan when it should be using the ct density. if the ct density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose., a resolution for this problem will be available in patch release 4.80.03 and release 5.00.01.
  • Acción
    Software to be upgraded

Device

Elekta Xio RTP System
  • Modelo / Serial
    Model: MUJ, Affected: , Software version: Versions 4.50 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

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