Events

Retiro De Equipo (Recall) de All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta Pty Ltd.

¿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
    RC-2013-RN-00667-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00667-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Elekta has advised that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator.
  • Acción
    Elekta are asking users to check all affected machines against the default auto-tracking settings. A software update will be provided as a permanent fix. This action has been clsoed-out on 01/02/2016.

Device

All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads
  • Modelo / Serial
    All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric HeadsARTG Number: 111760
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA