Events

Retiro De Equipo (Recall) de MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatment planning and delivery)Sites affected will be those meeting ALL three criteria below:1) Running MOSAIQ Release 2.41 and higher 2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy) 3) Who are treating with Stereotactic Cones

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-00608-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-07
  • 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-00608-1
  • 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
    A problem exists in mosaiq resulting in the incorrect field size being sent to the treatment machine for stereotactic plans. when a stereotactic field is imported or promoted, and the treatment field definition is opened:- the mlc shape will be correct for the planned cone field size, and- the user will also see the field size displayed with x=40 and y=the jaw setting for the planned cone. if simple mlc is selected, without changing the jaw size, the mlc shape will move the virtual x jaw to its most retracted position of 40. when the user clicks “ok” to accept the field change, they are presented with the field delta window and they must click “accept” for the change to take effect. if the mlcs are not edited to return to the correct shape for the planned cone, the user can unintentionally save the virtual jaw settings as the mlc shape resulting in a treatment field much larger than intended. the problem occurs because simple mlc is resetting the mlc positions.
  • Acción
    The problem can be avoided by clicking Cancel on the Create Simple MLC window, editing the field size values in the Create Simple MLC window to return to the correct MLC shape for the planned cone before saving or by not using the Simple MLC view. This problem will be resolved in a future release of the current MOSAIQ versions 2.41, 2.50, 2.60, 2.62. Elekta will inform the affected customers when the relevant MOSAIQ build is released containing the fix. This action has been closed-out on 8/08/2016,

Device

MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatme...
  • Modelo / Serial
    MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatment planning and delivery)Sites affected will be those meeting ALL three criteria below:1) Running MOSAIQ Release 2.41 and higher2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy)3) Who are treating with Stereotactic Cones ARTG: 206321
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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