Events

Rappel de INNOVA E5 CMS

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

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
    82415
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-06-14
  • 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
    This recall is being initiated by the manufacturer to reduce the chance of a blockage and improve the flow of water and chemical through the nozzle within the unit that would connect the 7th channel in a 7-channel scope to the innova unit. the size of this nozzle is currently 0.2 mm and it will be replaced by a 0.5 mm nozzle.

Device

INNOVA E5 CMS
  • Modèle / numéro de série
    Model Catalog: E5CMS-DC-EFF (Lot serial: 69880002); Model Catalog: 50600.96 (Lot serial: 69880002); Model Catalog: 50600.95 (Lot serial: 69880002); Model Catalog: 50600.94 (Lot serial: 69880002); Model Catalog: E5CMS-DH-EFF (Lot serial: 69880001); Model Catalog: E5CMS-DH (Lot serial: 69880001); Model Catalog: E5CMS-DC-EFF (Lot serial: 69880001); Model Catalog: E5-CMS (Lot serial: 69880001); Model Catalog: 50600.97 (Lot serial: 69880001); Model Catalog: 50600.96 (Lot serial: 69880001); Model Catalog: 50600.95 (Lot serial: 69880001); Model Catalog: 50600.94 (Lot serial: 69880001); Model Catalog: E5CMS-DH-EFF (Lot serial: 68881004); Model Catalog: E5CMS-DH (Lot serial: 68881004); Model Catalog: E5CMS-DC-EFF (Lot serial: 68881004); Model Catalog: E5-CMS (Lot serial: 68881004); Model Catalog: 50600.97 (Lot serial: 68881004); Model Catalog: 50600.96 (Lot serial: 68881004); Model Catalog: 50600.95 (Lot serial: 68881004); Model Catalog: 50600.94 (Lot serial: 68881004); Model Catalog: E5CMS-DH-EFF (Lot serial: 688810
  • Description du dispositif
    INNOVA E5 CMS;INNOVA E4 CMS
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Adresse du fabricant
    TORONTO
  • Société-mère du fabricant (2017)
    Scican Ltd
  • Source
    HC