Events

Retiro De Equipo (Recall) de Digital Accelerators with iViewGT or XVI

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-2017-RN-01480-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-12-04
  • 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-2017-RN-01480-1
  • 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
    Elekta has identified that if the microswitch in the pcb assembly, solenoid limit switch of the middle arm is not set up correctly, it is possible to get an uncontrolled extension of mv or kv detector arms. it is possible that a collision with the extended arm can cause serious injury. when the detector arm is fully extended there is no risk.
  • Acción
    Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions for use (IFU). iViewGT Elekta recommends that the detector panel is not opened or closed when the gantry is at 180° (±45°), especially when a patient is on the treatment table. The movement of the MV detector panel at these angles can disturb a patient if they are below the detector panel. XVI Elekta recommends that you do not open or close the detector arms when they are in a position above the patient. Distribute the supplied notice to all users of the system at your facility. Include a copy of the supplied notice with the system manuals. To acknowledge the receipt of this letter please complete the Confirmation of receipt form you receive from Elekta's automated distribution system. Return the form even if you no longer have the affected units at your site.

Device

Digital Accelerators with iViewGT or XVI

Manufacturer

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