Events

Retiro De Equipo (Recall) de Monaco 5.10.00(Radiation therapy treatment planning 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 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-2015-RN-00910-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-16
  • 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-2015-RN-00910-1
  • 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
    1)dose and mu incorrect when ct images viewed from the head: ct images are typically presented as if the viewer is standing at the foot of the couch and looking toward the patient’s head. however, for neurosurgery, images are often created as if being viewed from the top of the couch looking toward the patient’s feet. when ct images are created this latter way and imported in monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. the dose distribution and monitor units will be incorrect. 2)dose and mu incorrect when using multiple prescriptions with forced densities:when using multiple prescriptions and the first prescription has forced densities, these forced densities are not being maintained with the second prescription. the dose distribution and monitor units will be incorrect as the initial prescription will use forced densities and the second prescription will use ct densities.
  • Acción
    Elekta is advising customers that both problems will be resolved in Monaco Patch Release 5.10.01 which will be available for general release in late September. This action has been closed-out on 19/08/2016.

Device

Monaco 5.10.00(Radiation therapy treatment planning system)

Manufacturer

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