Events

Retiro De Equipo (Recall) de iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment)

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-2016-RN-01116-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-25
  • 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-2016-RN-01116-1
  • 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
    Iguide monitors if the hexapod is in the pre-defined 3d position. if it is not in this position an inhibit is set. for 3d treatments there is no iguide interlock check possible. in the event of a malfunction of the interlock system an inhibit in iguide may not lead to an external inhibit on the linac. there is the potential for unrecognised incorrect position of the treatment couch in 3d workflow, i.E. the hexapod has not moved fully to the 3d position.
  • Acción
    Elekta is advising user that if users do not intend to use iGUIDE for patient positioning, make sure the HexaPOD is at its pre-defined 3D position before treatment. The 3D position is confirmed in the iGUIDE login screen (no inhibit icon) or in the iGUIDE System Overview. In addition the External Inhibit LED at the Enable Switch Board must be off. It is recommended to perform the Interlock Check in the iGUIDE software on a daily basis. This information has been included in the Instructions For Use (IFU). This action has been closed-out on 09/05/2017.

Device

iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient pos...
  • Modelo / Serial
    iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) ARTG Number: 187340
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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