Events

Rappel de OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE

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
    131453
  • 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 optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. the optical guidance camera has not been evaluated for stability beyond a 24 hour time period and must be recalibrated at least once every 24 hours. this issue is most likely to be found in units upgraded to the 2.6.X software as older versions of the software allowed users to set calibration time outs greater than 24 hours. however all users should check their settings as described. in particular this issue may be found in sonarray systems where users may have increased the calibration time out beyond the factory settings.

Device

OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Modèle / numéro de série
    Model Catalog: 97530203A (Lot serial: NZ17010); Model Catalog: 97530203A (Lot serial: HZ19078); Model Catalog: 97530203A (Lot serial: HZ12066)
  • Description du dispositif
    OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.