Events

Retiro De Equipo (Recall) de XiO Software build versions 4.1 and higher (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-2014-RN-00275-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-03
  • 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-2014-RN-00275-1
  • 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
    Dose and monitor unit values are not computed correctly when elekta motorised wedges are used with dynamic conformal arcs. the problem occurs because only the start and stop angles of the dynamic conformal arcs are computed when all sub-beams of the arc should be computed. the planned dose distribution will not reflect the delivered dose. some anatomical structures will receive more dose than the plan reflects, some will receive less dose. it is possible that the target could likewise receive more or less dose than what is reflected in the plan. there is a remote probability of a mistreatment resulting in serious injury.
  • Acción
    Users are advised that the problem can be avoided by not using Elekta Motorised Wedges with Dynamic Conformal arcs. The problem was introduced in XiO Release 4.1 and will be resolved in Release 5.00.01 which will be released by March/April 2014.

Device

XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)
  • Modelo / Serial
    XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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