Events

Rappel de ExacTrac 5.5.5 (Image guided radiation therapy 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-2014-RN-00439-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-14
  • 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-2014-RN-00439-1
  • 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
    When using a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. if the anomaly occurs, the information displayed by exactrac under “external name” and “dicom patient coordinates” might not be correctly related to the information simultaneously displayed within the “image set reconstruction” picture and under “brainlab coordinates”. such a display of inconsistent positioning information might mislead the user when selecting a treatment plan / isocenter in exactrac for patient positioning. if not detected by the user, this might result in a patient and treatment target position at the linear accelerator (linac) that is different than intended. as a consequence the treatment dose might be delivered to a region different from the intended target region.
  • Action
    Customers are advised to continue to always follow the instructions and warnings as described in the user guide. Brainlab also recommends: - To enter meaningful plan comments during treatment planning. When selecting a plan in ExacTrac, before proceeding with patient positioning, always review this comment within ExacTrac together with the plan date. - To always verify the correct isocenter position inside the “Image Set Reconstruction” picture before proceeding with patient positioning. Brainlab will provide a software update to the affected customers which will resolve the issues identified.

Device

ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)
  • Modèle / numéro de série
    ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)Product Version Number: ExacTrac 5.5.5ARTG Number: 121226
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd