Events

Retiro De Equipo (Recall) de Elekta Integrity Digital Linear Accelerator, version 1.1

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-00334-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-17
  • 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-00334-1
  • 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
    If the "static tolerances" in the calibration files (loaded database) for the unwanted movement during the beam delivery are incorrect, the unwanted movement may not terminate treatment. this is only a problem if a malfunction such as a brake failure or an equivalent fault occurs during beam delivery.
  • Acción
    Elekta is advising that the solution to the problem is to apply the Integrity 1.1 Static Tolerance Updater Tool. This tool will need to be re-applied, if a new Linac license is applied in the future. A complete solution will be included in the next release of the software.

Device

Elekta Integrity Digital Linear Accelerator, version 1.1
  • Modelo / Serial
    Elekta Integrity Digital Linear Accelerator, version 1.1ARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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