Events

Rappel de Philips Pinnacle Radiation Treatment Planning System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Radiation Oncology Systems.

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
    17325
  • Date de mise en oeuvre de l'événement
    2014-09-09
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 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.
  • Action
    Software to be upgraded

Device

Philips Pinnacle Radiation Treatment Planning System

Manufacturer

Philips Radiation Oncology Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA