Events

Rappel de MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Elekta 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-2016-RN-00781-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-14
  • 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-2016-RN-00781-1
  • 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
    Clicking on the treat button in the treatment chart window will trigger the plan-of-the-day iq script to run. the plan-of-the-day window will open and the treatment plan can be selected by clicking on the radio button. it is possible that the selected plan-of-the-day could be accidentally changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.Though the wrong plan-of-the-day selected for one fraction would likely not result in critical harm, if the wrong plan were selected multiple times it could result in serious injury.
  • Action
    The issue is corrected in the general release of MOSAIQ 2.64. A software patch will be released for MOSAIQ version 2.62 in order to correct the defect. In the interim, the problem can be avoided by careful use of a mouse with a wheel (or using a mouse without a scroll wheel) and verifying that the correct plan is chosen before selecting OK on the Plan-of-the-Day form. This action has been closed-out on 02/02/2017.

Device

MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to m...
  • Modèle / numéro de série
    MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA