Events

Retiro De Equipo (Recall) de Monaco V 5.11 and V 5.20 (used for radiation treatment 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-2016-RN-01421-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-03
  • 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-2016-RN-01421-1
  • 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
    It has been identified that when running monaco v 5.11 or v.5.20 and creating 3d plans and using elekta motorized wedges, that the dose can be incorrectly calculated when using the reset function in monaco. when creating 3d plans using dose weighting mode, if the user rescales the plan, selects “reset”, and then changes the wedge angle, the plan dose and monitor units (mu) should be returned to the original values before the rescale. instead, the system correctly restores the edited wedge field but incorrectly applies the scale reset value again to all other beams in the plan. the clinical impact is that the mus are correct for the non-wedged beams but the dose being presented on the screen is incorrect. therefore the dose displayed will not be what is delivered.
  • Acción
    Elekta is advising users that the issue will be resolved with Monaco software releases V 5.11.02 and 5.30, which have estimated release dates of end of January 2017 and end of March 2017, respectively. Elekta is also advising users that, in the interim, the problem can be avoided by forcing a Monaco recalculation (change dose calculation grid spacing and change back) when any wedge angle change is made.

Device

Monaco V 5.11 and V 5.20 (used for radiation treatment planning)
  • Modelo / Serial
    Monaco V 5.11 and V 5.20 (used for radiation treatment planning) ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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