Events

Retiro De Equipo (Recall) de Monaco V5.10 and V5.20 (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-01281-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-28
  • 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-01281-1
  • 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 5.10 or v 5.20 and creating 3d plans using either mu or dose weighting modes, if the user changes the physician's intent rx dose and the number of fractions, and then modifies the wedge angle, the monitor unit (mu) value is scaled incorrectly. the scaling of the mu is in direct proportion to the fractional change.If the mus are not correct, the patient will be incorrectly treated. there could be a critical overdose or underdose proportional to the fractional rescale. however, prior to treatment, independent dose calculation checks and secondary mu checks should always be done. both should be standards of practice in radiation therapy clinics and will detect the problem.
  • Acción
    Elekta is advising users that the issue is resolved with Monaco release 5.11.00 which is available now and with patches for versions 5.10 and 5.20. Elekta is also advising users that dose calculation checks and secondary MU checks should detect the problem, and that 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 V5.10 and V5.20 (used for radiation treatment planning)
  • Modelo / Serial
    Monaco V5.10 and V5.20 (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