Events

Retiro De Equipo (Recall) de Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)

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-00410-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-06
  • 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-00410-1
  • 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
    There is a potential for incorrect mounting of the frame adapter to the coordinate frame. the latches of the frame adapter can be locked even if the locating pins of the frame adapter are not inserted into the corresponding holes in the coordinate frame. if the frame adapter is mounted incorrectly to the coordinate frame and this is not noticed by the user before treatment is started, dose will be delivered in the wrong place by up to 2cm.
  • Acción
    Elekta is advising users that the frame adapter is safe to use provided that the Instructions for use are followed and conducted by a trained professional. It is of the highest importance that the frame adapter is mounted to the coordinate frame as described in the applicable Instruction for Use. The locating pins of the frame adapter shall be inserted into the corresponding holes in the coordinate frame before the three latches are locked. Also make sure that only trained personnel are involved in mounting the frame adapter. A field corrective action will be implemented to facilitate a correct mounting of the frame adapter.

Device

Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of he...
  • Modelo / Serial
    Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)ARTG Number: 182102
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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