Events

Rappel de OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM

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
    71454
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-06-28
  • 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
    The initial date assigned to the plan is the date of the data transfer. this date is updated when any 'new' file is written into the directory. this date may change when performing other functions with a transferred patient file such as saving pre- recorded positions fiducial registration and report or patient settings. therefore exam transferred at time 't' but opened for a quick review in 't'+t may have the later timestamp leading to confusion at the time of exam selection. the risk is a user opens a previous exam for review and then 'saves' the file. they then go to open today's exam however they select the most recent exam (the one they just opened reviewed and saved) thinking it is treatment plan for the day when it is not.

Device

OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Modèle / numéro de série
    Model Catalog: 97525005A (Lot serial: HZ12066); Model Catalog: 97525005A (Lot serial: HZ17010); Model Catalog: 97525005A (Lot serial: HZ19078)
  • Description du dispositif
    OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.