Events

Retiro De Equipo (Recall) de Monaco software versions 5.10.00 and higher

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-00651-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-25
  • 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-00651-1
  • 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
    When dicom is exporting a 3d monaco plan and the “composite field sequencing” (cfs) checkbox is selected, the y jaws will snap to the port shape when they should remain where they were defined. this occurs when the port shape used to define or edit the mlc positions extends beyond or inside the actual jaw positions. the defect is triggered when using a workflow for forward planning imrt that involves creating multiple beams for the same gantry angle with a single mlc shape defined for each beam. these beams are then exported using cfs to combine the individual 3d beams into a single imrt beam sequence. the planned and approved dose distribution will not agree with the dose delivered. this deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the mlc shape is drawn outside or inside of the collimator jaws. there is a remote probability that serious injury could occur.
  • Acción
    Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction. This action has been closed-out on 09/05/2017.

Device

Monaco software versions 5.10.00 and higher

Manufacturer

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