Events

Retiro De Equipo (Recall) de ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab Australia 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-00218-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-08
  • 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-00218-1
  • 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 performing a snap verification, that is a monoscopic intra-fraction x-ray monitoring using only one x-ray tube, in combination with implanted markers, the exactrac 6.0 x-ray monitoring tab might display an incorrect hint icon and result text. exactrac might incorrectly show the hint icon in green colour with the result text “no deviation detected”, despite the simultaneously displayed unaffected x-ray image showing the actual positions of the implanted markers potentially deviating from the user defined tolerance areas .
  • Acción
    Brainlab is asking customers to always verify the result of a Snap verification within the simultaneously displayed x-ray images generally required and never exclusively rely on the hint icon colour and the result text only. Brainlab will provide a software update to affected customers around end of August 2013 to correct the issue.

Device

ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)
  • Modelo / Serial
    ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)ARTG: 121226
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd