Events

Retiro De Equipo (Recall) de ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning

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-2017-RN-01283-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-13
  • 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-2017-RN-01283-1
  • 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
    Elekta has become aware of the potential for incorrect dicom mapping of the exported collimator or couch angles from ergo. this would lead to incorrect rotation of the collimator or couch when using a mlc device for planning.If the dicom export values are not mapped correctly, it is possible that treatments could be delivered with the wrong collimator or couch angle. in the event patients were treated with the wrong collimator or couch angle, this would result in a geometric miss with the tumour being potentially under-dosed and normal structures overdosed.
  • Acción
    Elekta is advising users who are using MLC for dose planning in ERGO to run a verification test to ensure that the collimator and couch are rotating correctly. If the verification test fails please contact the Elekta Care Support Centre for assistance.

Device

ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
  • Modelo / Serial
    ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planningARTG Number: 187299
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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