Events

Rappel de Standard Cranial Reference Array (used with Vector Vision Cranial Navigation 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-2012-RN-00962-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-24
  • 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-2012-RN-00962-1
  • 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
    Manufacturing tolerance's of the standard cranial reference array influence the actual position of its marker spheres. the differences between the individual arrays are very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery.This recall action was not notified to the tga before it was initiated by brainlab australia.
  • Action
    The sponsor is advising users to follow work around instructions and will provide a hardware update to correct the issue.

Device

Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)
  • Modèle / numéro de série
    Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)Product Codes: 41735 & 41730A
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd