Events

Retiro De Equipo (Recall) de Elekta Focal Radiation Therapy Treatment Planning Systems

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
    17182
  • Fecha de inicio del evento
    2014-08-15
  • 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 dicom exporting an arc plan (vmat, dynamic conformal or 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan., the problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. cfs is designed to combine arcs into a single beam to streamline delivery. however, under these specific circumstances, the start and stop points for the arcs become corrupted.
  • Acción
    Software to be upgraded

Device

Elekta Focal Radiation Therapy Treatment Planning Systems
  • Modelo / Serial
    Model: , Affected: , Software version: Focal 4.7 and 4.8 when using Elekta or Siemens linacs
  • Manufacturer
    Elekta Inc

Manufacturer

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