Events

Rappel de Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2014-RN-00975-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-09
  • 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-2014-RN-00975-1
  • 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
    The issue occurs under certain specific conditions where the user modifies a contour in a density-overridden rol (region of interest) with density set to a specific value in a computed plan. dose is subsequently invalidated and the user may recompute the dose. in this case, the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose, and the monitor units (mu) may then be much higher than originally planned. the user may continue, and save the plan with incorrect dose. when the plan is reopened, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.An incorrect radiation dose to the target or other structures could occur. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • Action
    Version 9.8 corrects the issue. Philips recommends that user always use version 9.8 or above for patient planning. Philips will provide version 9.8 to those customers that still have version 9.0, 9.2, 9.4 or 9.6. This action has been closed-out on 17/08/2016.

Device

Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System)
  • Modèle / numéro de série
    Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System)ARTG Number: 118156
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA