Events

Rappel de Brainlab Cranial Navigation System, all versions

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-2013-RN-00397-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • 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-2013-RN-00397-1
  • 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 detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy:- large distance between reference array and region of interest- major changes of the camera position relative to the reference array during the procedure.
  • Action
    Brainlab are providing additional instructions for use regarding the correct use of the Brainlab Cranial Navigation System. End users are advised to continue to follow the instructions in the user manual and adhere to the measures documented in the additional instructions for use (Measures to Improve Cranial Navigation Accuracy).

Device

Brainlab Cranial Navigation System, all versions

Manufacturer

Brainlab Australia Pty Ltd