Events

Retiro De Equipo (Recall) de Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)

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-01187-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-11
  • 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-01187-1
  • 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
    In rare cases the xvi can incorrectly calculate the target position of the treatment table. the sequence of events when this error occurs is:- the user does an online volumeview acquisition and registration- the user accepts the registration and the table move assistant dialog box appearstwo different scenarios can result:- if the issue occurs only during initial patient set up the absolute actual column of the table move assistant dialog box incorrectly shows blank values. this error can cause a collision between the patient and the external beam limiting device but mistreatment cannot occur as it is not possible to get the table move assistant values in tolerance. - if the issue occurs at times other than initial patient set up the absolute actual column of the table movement dialog can display incorrect values. there is potential for clinical mistreatment if the relative set value is less than 01.Cm.
  • Acción
    Elekta is advising all affected users of the mandatory software upgrade which will prevent table movement if the start position has not been recorded correctly. A permanent solution for this problem is now available for all customers running XVI 5.0.0, XVI 5.0.1 systems. An Elekta service team member will contact the customers to install the software upgrade. This action has been closed-out on 07/06/2016.

Device

Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (Electronic Imaging D...
  • Modelo / Serial
    Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)ARTG number: 214673
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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