Events

Retiro De Equipo (Recall) de X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (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-2013-RN-01287-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-02
  • 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-2013-RN-01287-1
  • 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
    Xvi can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently.If the user does not monitor the patient and treatment table movements, and keeps the table automatic setup (asu) buttons pressed, the treatment table continues to move. it only stops when a touchguard activates. this error can cause a collision between the patient and an external beam limiting device (bld) if: the external bld does not operate with the touchguard attached, or if the external bld extends out more than the touchguard. if the error occurs, fatal injury to the patient could occur. when the error occurs, it is not possible to get the table move assistant values in tolerance. therefore, it is not possible to apply an incorrect correction to the patient position before treatment delivery.
  • Acción
    Elekta is providing work around instructions for users to follow. Elekta is advising users to monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the function keypad (FKP). To correct the error, users are advised to restart the XVI, place patient in initial set up position and scan the patient again and continue the usual workflow. A software update will be released for upgrading all XVI R4.5, R4.5.1, R4.6 users to XVI 5.0. A fix to resolve the issue will be developed for XVI R5.0 which is estimated for completion in December 2014.

Device

X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (Electronic Imag...
  • Modelo / Serial
    X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (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