Events

Retiro De Equipo (Recall) de EXACTRAC 6.x (Image Guided RadiationTherapy 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-00204-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-03-13
  • 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-00204-1
  • 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
    Brainlab has internally detected an unexpected phenomenon for exactrac v.6.X that could occur when using the exactrac cone beam ct (cbct) module in combination with actively re-reconstructed cbct images of a subvolume from the original cbct volume. if a user-defined actively re-reconstructed cbct subvolume is imported into exactrac, exactrac cannot regard the position of this cbct subvolume correctly. if the center of this subvolume differs from the center of the original cbct volume, this leads to an erroneous calculation of patient shifts needed to move the patient to the planned treatment position. if the corresponding calculated shifts and rotations are applied with exactrac, the patient will be positioned incorrectly at the linac. if not detected by the user, the radiation treatment dose at the linac may be delivered to an unintended target position. if the deviation exceeds clinically acceptable limits, this could result in mistreatment, serious patient injury, or even death.
  • Acción
    Affected customers will be contacted starting August 2015 to schedule the installation of the software update In the interim, customers are advised to not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module with immediate effect. Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning. Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. This action has been closed-out on 1/06/2016.

Device

EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)
  • Modelo / Serial
    EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)Product Version Number: ExacTrac 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0ARTG Number: 121226
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd