Events

Rappel de EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00204-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00204-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd