Events

Rappel de RTVUE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CLARION MEDICAL TECHNOLOGIES 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
    135258
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-04-18
  • 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
    A minor software upgrade for optovue device families were released on february 22 2016. the device families are the ivue (rtvue - ivue100) ifusion and ivue500 (iscan in the us). the software configuration is 2016.1.0.127 (outside the us only). the device user will perform a scan of a patient's retina. they may then review the data within a series of available reports. two reports are affected by the software anomaly: (1) retina map ou report and (2) iwellness ou report. for example in the new retina map ou report the user may scroll on the map" or the "b-scan" image of either eye. this activates the software anomaly and makes both b-scans identical (i.E. - both show the same eye). whether both eyes become left or right depends on how you enter the report. for example entering the ou report from the od (right eye) report will cause both b-scans to be right eye when scrolling is attempted.

Device

RTVUE
  • Modèle / numéro de série
    Model Catalog: IVUE100 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    RTVUE OCT SCANNER
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.