Events

Rappel de VariSource iX Control Software

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia 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-01010-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-15
  • 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-01010-1
  • 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
    An anomaly has been identified with the varisource ix control software. in the event a forced logoff occurs while the dummy wire is extended during a treatment session, the partial fraction generated by the system will be incorrect. the control software does not differentiate the re-start dummy sweep from the dummy sweep at the beginning of the treatment session. the control software assumes no treatment has been delivered. the partial fraction generated will be equivalent to the original full fraction. if this partial fraction is treated, this would result in re-treatment of any dwell positions actually delivered prior to the session interrupt and result in a dose greater than intended. the treatment recovery report will incorrectly indicate that no dwell positions have been treated. both the treatment delivery report and the treatment history report do correctly indicate the dwell positions treated.There have been no reports of patient injury due to this issue.
  • Action
    Varian Medical Systems is developing a technical correction for this issue. A Technical Service representative will contact the affected hospital when this correction is available to schedule its installation. In the interim a workaround is provided in the Customer Letter.

Device

VariSource iX Control Software
  • Modèle / numéro de série
    VariSource iX Control SoftwareAffected Versions/Lots: Version 1.2.1, Build 3726 and Version 1.2, Build 2.4336 ARTG Number: 119982
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd