Events

Retiro De Equipo (Recall) de Elekta Precise Treatment Table

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
    17222
  • Fecha de inicio del evento
    2014-08-22
  • 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
    Manufacturer identified that it is possible to get a positional error with the precise treatment table. this can occur if the positional sensors are not correctly installed during corrective maintenance. the system has a software check for large positional errors which is intended to find faults, but it is possible to position the treatment table with errors greater than 5mm and no inhibits are displayed., it is possible to cause a clinical mistreatment if the patient is not in the correct position.
  • Acción
    Manufacturer to issue advice regarding use

Device

Elekta Precise Treatment Table

Manufacturer

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