Events

Retiro De Equipo (Recall) de XVI R3.5, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy)

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-00074-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-25
  • 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-00074-1
  • 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
    In some treatment planning systems, the users can contour more than one region of interest with the same structure name. the dicom tags do not contain sufficient information for xvi to identify the different volumes that have the same name. therefore, if the user use dicom rt to send these volumes as one list of contours, it can cause xvi to: - interpolate a contour that identifies the two structures as one structure. - change the contour shape of the volumes in the imported ct reference data and structure sets.
  • Acción
    Elekta is advising users to ensure that fields are correct when importing patient data from the treatment planning system (TPS) and to give different volumes different structure names as a work around. A software release will be provided to correct the issue.

Device

XVI R3.5, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and su...
  • Modelo / Serial
    XVI R3.5, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy)ARTG Number: 165039
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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