Events

Retiro De Equipo (Recall) de Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with 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-2013-RN-00532-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-03
  • 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-2013-RN-00532-1
  • 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
    After the mandatory upgrade of xvi systems from xvi r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3), elekta has found that some customers are still operating on the incorrect software build of the xvi r4.5.1 b138 software. the correct build is r4.5.1 b141. the software update from r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3) was to permanently correct a software problem that prevents the operation of the database reindex function and also, prevents the error that incorrectly causes a kv gating inhibit during segmental volumeview.
  • Acción
    If XVI Release 4.5.1 b141 is displayed on the logon screen, no further action is required. If XVI Release 4.5.1 b138 is displayed end users must contact their service representative immediately. Instructions to complete the upgrade to the correct software build are also being provided to end users.

Device

Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation thera...
  • Modelo / Serial
    Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)Software version 4.5.1 b138ARTG number: 165040
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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