Events

Retiro De Equipo (Recall) de Hexapod iGUIDE 2.1, iGUIDE 2.2

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-2016-RN-00636-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-19
  • 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-2016-RN-00636-1
  • 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
    The manufacturer has identified a software issue which may lead to incorrect patient positioning during treatment. in a specific scenario the software may prompt the user several times to move the hexapod to its drive (*start) position. if the user follows this request the hexapod will move to drive (*start). in a consecutive step iguide shows hints to move the couch top with the precise table back to the initial imaging position. however, this position is reached only with a coarse movement. the final fine adjustment move, executed by the hexapod, is missing. the coarsely reached imaging position becomes the new registered position for the actual position error correction (pec) movement to the target position. a theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement.
  • Acción
    Electa advises users to avoid imaging in the PARK (*LOAD) position. If the user has performed imaging when the HexaPOD is not in the DRIVE (START*) position, cancel all move to DRIVE (START*) requests. Thus the HexaPOD remains in the imaging position. If the user then applies the PEC the HexaPOD will reach the target in the specified accuracy. The movement to the target will be a combination of Precise Table and HexaPOD moves. In case of any doubts perform a verification scan. A software update which will correct the behaviour of the affected iGUIDE versions 2.1 and 2.2 will be provided to the affected customers free of charge as soon as it becomes available.

Device

Hexapod iGUIDE 2.1, iGUIDE 2.2

Manufacturer

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