Events

Rappel de VARISEED 8.0

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par VARIAN MEDICAL SYSTEMS INC..

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
    90283
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-07-03
  • 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
    Some variseed users have inadvertently entered a source activity in units of air kerma (u) when the actual source activity was specified in millicuries (mci). variseed requires the user to enter the activity of the source that will be implanted into the patient. the activity may be entered in "u" or "mci". when entering the activity in u the value is accepted and no further message is displayed. if the activity is entered as mci a message is shown indicating that variseed will show "u" in the user interface from that point on and notifying the user of the convered value in u. a data entry error of this nature should be obvious to the user. the variseed software system provides a message at the time data is entered that the user has to click to accept and move forward in planning. also both units of activity are shown on the variseed report headers.

Device

VARISEED 8.0
  • Modèle / numéro de série
    Model Catalog: 8.0 (Lot serial: Contact manufacturer.); Model Catalog: 8.0 (Lot serial: >10 serial numbers.)
  • Description du dispositif
    Variseed 8.0 (Brachytherapy Treatment Planning System)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.