Events

Retiro De Equipo (Recall) de EXACTRAC Version 6.0.0 through to 6.0.5 (Image Guided Radiation Therapy Patient Positioning System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab Australia 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-2015-RN-00731-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-12
  • 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-2015-RN-00731-1
  • 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
    Loading and processing of large treatment plans, e.G. with a large image scan range and with a high number of outlined contours, may lead to an error in the exactrac internal graphic memory. after such a memory error has occurred, this might, under specific conditions, cause exactrac to display the digitally reconstructed radiograph (drr) of the previously loaded patient data set instead of the correct drr during the positioning workflow of any subsequently opened patient treatment plan until the exactrac application is restarted.This issue affects x-ray correction and verification based on bony fusion to the drr. the xray images acquired for current patient positions are not affected and still correct even if this issue occurs. only if the mismatch of displayed patient image data in exactrac is not discovered by the operator, the incorrect drr might be used for image fusion to the acquired x-ray images, potentially resulting in the calculation of an incorrect shift.
  • Acción
    Brainlab will provide a software revision (ExacTrac v. 6.0.6) with this issue solved to affected customers.Brainlab will contact affected customers starting December 2015 to schedule the update. In the interim, to minimise the probability of this issue to occur for the affected ExacTrac versions: - Reduce the amount of contours exported to ExacTrac as far as possible (export only contours needed for positioning to ExacTrac). - Avoid exporting large contours, such as couch top models, to ExacTrac. - After every (re-)start of the ExacTrac application on any workstation, always first load a phantom plan not containing contours. Generate DRRs of that phantom plan once by selecting the Define DRR Settings tab, before loading any other patient treatment plans. This action has been closed-out on 17/08/2016.

Device

EXACTRAC Version 6.0.0 through to 6.0.5 (Image Guided Radiation Therapy Patient Positioning System)
  • Modelo / Serial
    EXACTRAC Version 6.0.0 through to 6.0.5 (Image Guided Radiation Therapy Patient Positioning System)Versions: 6.0.0; 6.0.1; 6.0.2; 6.0.3; 6.0.4; 6.0.5ARTG Number 121226
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd