Events

Rappel de ONCENTRA Brachy version 3.x and 4.x

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Nucletron Pty Limited.

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-00448-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-27
  • 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-00448-1
  • 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
    In oncentra brachy (brachy planning (bp) module and plan analysis (pa) module) dose may be incorrectly calculated for regions of interest (rois) defined on a secondary image series when using specific registration methods. the magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value.
  • Action
    A software patch is in development to correct this issue and is expected to be released end of November, 2015. Nucletron will work with their customers to implement the patch on affected devices. In the interim, end users are advised to resample Regions of Interest defined on a secondary image series onto the primary image series prior to dose evaluation. This action has been closed-out on 4/08/2016.

Device

ONCENTRA Brachy version 3.x and 4.x

Manufacturer

Nucletron Pty Limited