Events

Rappel de NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-00502-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • 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-00502-1
  • 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
    Ndi determined that drms spheres from lot c102061501 may break apart at the mid-point where the two halves of the sphere are sealedtogether, either during installation onto reference arrays or surgical tools (i.E., when threading them onto posts), or any time during a surgical procedure.One failure of this nature has been reported, with no report of injury or death.
  • Action
    Life Healthcare is requesting their customers to quarantine any affected stock. Life Healthcare will provide replacement stock where required. This action has been closed-out on 10/08/2016.

Device

NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-g...
  • Modèle / numéro de série
    NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)Lot C102061501ARTG Number: 182255
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd