Events

Rappel de PINNACLE THERAPY PLANNING SYSTEM - KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS 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
    28489
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-08-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Philips has become aware that the dose may be inconsistent with the density of a density-overriden roi (region of interest). the issue occurs under certain specific conditions where the user modifies a contour in a density-overridden roi (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 origianlly 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.

Device

PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Modèle / numéro de série
    Model Catalog: 453560453781 (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Description du dispositif
    PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC