Events

Retiro De Equipo (Recall) de Apex (Multileaf collimator used with Elekta linear accelerators)

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-00083-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-30
  • 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-00083-2
  • 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
    If the apex collimator has not been correctly installed on the radiation head and the user use the touchguard button to override the touchguard inhibit and rotate the gantry, the apex collimator can disconnect form the radiation head. this can occur because a fault condition that shows that the apex collimator was not attached correctly is bypassed.
  • Acción
    Users are requested to include additional safety information provided with the customer letter in the instructions for use. The safety information requests users to ensure that they do not override the touchguard inhibit or rotate the gantry after installing the Apex collimator. The safety information also informs users that the View Restrictions dialogue box may not show the touchguard inhibit restriction if there are other restrictions present.

Device

Apex (Multileaf collimator used with Elekta linear accelerators)
  • Modelo / Serial
    Apex (Multileaf collimator used with Elekta linear accelerators)ARTG Number: 186855
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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