Events

Retiro De Equipo (Recall) de Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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-2012-RN-00652-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-02
  • 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-2012-RN-00652-3
  • 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
    A software anomaly has been identified with the eclipse treatment planning system where changing the prescription in a calculated vmat or rapidarc plan may lead to monitor units which do not reflect the new prescription. if the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimisation, the monitor units and dose distribution may not reflect the intended prescription.
  • Acción
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 1...
  • Modelo / Serial
    Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11Multiple Serial Numbers affectedProduct Code: H48ARTG Number: 119983
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd