Events

Retiro De Equipo (Recall) de Monaco

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
    20997
  • Fecha de inicio del evento
    2017-01-10
  • 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
    The manufacturer has indentified that calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorized wedge. the user must change the beam index numbers belonging to the two wedged beams, such that the index numbers have been exchanged for these beams, then edit the wedge angle of one of the beams.
  • Acción
    Manufacturer to issue advice regarding use

Device

Monaco
  • Modelo / Serial
    Model: , Affected: Running Monaco: V 5.10.00 (including 5.10.01, 5.10.02), or V 5.11.00 (including 5.11.01), or V 5.20.00, and Using Elekta Motorized Wedges
  • Manufacturer
    Elekta Inc

Manufacturer

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