Events

Rappel de ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment 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-00269-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-04
  • 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-00269-1
  • 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 multiple isocenters (multiple radiation treatment targets) within a single plan, if a specific workflow is used and certain variables relating the software timing and user interaction are met, exactrac v6.0.3 might position the patient to an unintended isocenter position.
  • Action
    Brainlab is requesting end users to avoid using treatment plans with multiple isocenters. If a plan with multiple isocenters cannot be avoided always close the patient ExacTrac after treatment of one isocenter is finished and reload the patient plan before selecting the next isocenter. Also, make sure to always select only one isocenter of the plan in ExacTrac in between opening and closing the patient. Brainlab will release a software update to correct the issue. Thia action has been closed-out on 28/01/2016

Device

ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient posit...
  • Modèle / numéro de série
    ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system)
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd