Events

Rappel de Pinnacle3 Radiation Treatment Planning System, software version 9.0

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-00291-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-11
  • 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-00291-1
  • 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
    When the user changes from one treatment machine to another, the jaw symmetry yes or no option may be set incorrectly to symmetric. when exported via dicom rt, multileaf collimator (mlc) and jaw positions agree with the pinnacle3 plan. however, because the jaw symmetry flag is set to yes, the record and verify (r&v;) system may force the jaws to be symmetric, thereby re-positioning the beam. the resulting beam on the r&v; system does not match the beam in pinnacle3 resulting in an incorrect dose to the target or other structure. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • Action
    Philips is providing an update to software version 9.2 to all customers who have software version 9.0 installed. Until the update is applied, customers are advised to manually cick the button to set it to No if they observe the jaw symmetry is set to Yes inappropriately.

Device

Pinnacle3 Radiation Treatment Planning System, software version 9.0

Manufacturer

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