Events

Retiro De Equipo (Recall) de Monaco V 5.00 and higher (Radiation therapy treatment planning system software)

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-01493-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-14
  • 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-01493-1
  • 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
    Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm. if the ct data contain slices that occur at positions of xx.X50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimisation and calculation of dose. unloading and reloading the patient data corrects the problem.Incorrect structure volumes can be used during optimisation. incorrect electron densities can be assigned to some regions of the patient.This can result in incorrect dose calculations. dose errors of greater than 5% can occur.
  • Acción
    This problem will be resolved in Monaco release 5.30 and in patches to Monaco releases 5.10 and 5.11. In the interim, the problem can be avoided if the user takes the following action: - Following contour edits, perform an “Unload All” and reload the plan prior to performing dose calculation. This action has been closed-out on 26/05/2017.

Device

Monaco V 5.00 and higher (Radiation therapy treatment planning system software)
  • Modelo / Serial
    Monaco V 5.00 and higher (Radiation therapy treatment planning system software)ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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