Events

Retiro De Equipo (Recall) de HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)

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-2014-RN-00612-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-06-03
  • 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-2014-RN-00612-1
  • 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
    The iguide key allows to the treatment of patients without using the hexapod evo rt system. when users turn the iguide key to the off position; the external inhibit signal is overridden and the iguide software closes any open fractions and logs off (login appears). in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when users turn the iguide key back to the on position, it will not set the external inhibit signal or alert them if the position has changed (ie, position guard is inactive). this problem can lead to clinical mistreatment if the user assumes that the iguide software is running correctly. the iguide software will not set the external inhibit signal or notify the user in case of incorrect positioning or movements.
  • Acción
    Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. A software update will be implemented on all affected systems that corrects the behaviour of the iGUIDE software. This action has been closed-out on 11/02/2016.

Device

HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within...
  • Modelo / Serial
    HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)ARTG Number: 187340
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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