Events

Rappel de Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1

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-00396-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-12
  • 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-00396-1
  • 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 navigation software offers automatic registration of ct image data sets, intraoperatively acquired with an integrated neurologica bodytom portable ct scanner (“bodytom”). in the course of clinical usage of these devices at different hospitals, registration inaccuracies have been identified in some instances when using automatic registration with bodytom. in these cases the data set could not be accurately registered to the actual patient anatomy when performing automatic registration. an accurate registration (match between ct image data set virtually displayed in navigation and the current patient anatomy) is essential for a successful navigation.If a potentially inappropriate registration is not detected during user verification, the deviation of the position information in the navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
  • Action
    To reduce the risk of an inappropriate automatic registration, Brainlab in cooperation with NeuroLogica has developed an improved integration and verification workflow to be followed by users which is provided with the customer letter. Brainlab will individually contact each affected customer to offer: a) a service visit to assist in the selection and marking of a suitable movement path and to perform the calibration and verification in cooperation with Neurologica. b) an additional training regarding the improved verification methods. This action has been closed-out on 08/08/2016.

Device

Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial ...
  • Modèle / numéro de série
    Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1 ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd