Events

Retiro De Equipo (Recall) de Oncentra RTP

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 Nucletron BV.

¿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
    21821
  • Fecha de inicio del evento
    2017-08-17
  • 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 default step size set in rdstore is typically used during the planning process. the measured source paths for a ring-type applicator always have a source step size of 2.5 mm for the microselectron afterloader. when creating an oncentra brachy plan for a ring applicator with a measured source path, the step size of the measured source path will be used for the entire plan., the issue is caused by the measured source paths for the applicators listed below, which have a source step size of 2.5 mm for the microselectron afterloader. if you use such an applicator model to create a plan, while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5 mm, while the afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
  • Acción
    Software to be upgraded

Device

Oncentra RTP
  • Modelo / Serial
    Model: , Affected: Oncentra Brachy versions 4.5, 4.5.1, 4.5.2.
  • Manufacturer
    Nucletron BV

Manufacturer

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