Events

Rappel de ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)

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-2012-RN-01084-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-10-24
  • 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-01084-1
  • 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 aria oncology information system version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued. the issue happens when a treatment is interrupted mid-field (for example, by a power loss) and the delivered monitor units for the partially treated field are entered manually in the treatment record. when the partial treatment is resumed, the system will not use the full remaining planned monitor units for the affected field, thus leaving the fraction under dosed.
  • Action
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the ...
  • Modèle / numéro de série
    ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)Product code: HITAffected serial numbers: HIT0339M and HIT0339R1ARTG Number: 132638
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd