Events

Rappel de TOMOTHERAPY TREATMENT SYSTEM - KIT POWER

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

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
    64899
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-12-28
  • 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
    Tomotherapy has discovered an anomaly during internal testing. if a tomodirect procedure which consists of 2 to 12 beam angles has an unrecoverable interrupt or emergency stop during a short time period between beam angles there is a small possibility that the procedure will indicate a "performed" status rather than "interrupted" on the operator station. if this occurs the user will not be able to generate a completion procedure. tomotherapy's investigation revealed that when an unrecoverable interrupt or emergency stop occurs with <1 second remaining in a tomodirect beam angle the logic in the software code checks if all the triggers (beam pulses) for the current beam angle is fully delivered and marks the procedure as "performed" rather than interrupted as intended. the anomaly is not taking into account if there are any remaining beam angles to be delivered.

Device

TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Modèle / numéro de série
    Model Catalog: 101264 (Lot serial: S/N: 10333); Model Catalog: 101264 (Lot serial: S/N: 10332)
  • Description du dispositif
    TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Adresse du fabricant
    MADISON
  • Société-mère du fabricant (2017)
    Accuray Inc
  • Source
    HC