Events

Rappel de XN-11 MODULE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SYSMEX CANADA 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
    22233
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-04
  • 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 protective plastic sheet that is intended to cover and protect electronic components inside the xn-series analyzers was not positioned correctly during manufacturing. reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. the salt build-up created a salt bridge that allowed current to continue to flow create heat and eventually ignite adjacent resin parts inside the analyzer.

Device

XN-11 MODULE
  • Modèle / numéro de série
    Model Catalog: XN-11 (Lot serial: A1001-A1124); Model Catalog: XN-11 (Lot serial: A1171); Model Catalog: XN-11 (Lot serial: A1163); Model Catalog: XN-11 (Lot serial: A1161); Model Catalog: XN-11 (Lot serial: A1151); Model Catalog: XN-11 (Lot serial: A1153-A1159); Model Catalog: XN-11 (Lot serial: A1146-A1149); Model Catalog: XN-11 (Lot serial: A1142-A1144); Model Catalog: XN-11 (Lot serial: A1127); Model Catalog: XN-11 (Lot serial: A1130); Model Catalog: XN-11 (Lot serial: A1135-A1140); Model Catalog: XN-10 (Lot serial: 29788-29798); Model Catalog: XN-10 (Lot serial: 29800-29801); Model Catalog: XN-10 (Lot serial: 29803); Model Catalog: XN-10 (Lot serial: 29804); Model Catalog: XN-10 (Lot serial: 11001 - 29656); Model Catalog: XN-10 (Lot serial: 29812); Model Catalog: XN-10 (Lot serial: 29816-29867); Model Catalog: XN-10 (Lot serial: 29668 - 29786); Model Catalog: XN-10 (Lot serial: 29807)
  • Description du dispositif
    XN-11 MODULE;XN-10 MODULE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Sysmex Corp.
  • Source
    HC