Events

Rappel de STATION UPGRADE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LEICA BIOSYSTEMS RICHMOND 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
    33127
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • 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
    Leica biosystems richmond inc. has identified a potential error on the cytovision image analysis and capture systems. an issue during the manufacturing process might have caused these systems to have an improperly activated windows 7 operating system even though a valid windows 7 license was associated with each manufactured system. it has been determined these systems cannot be re-activated using standard windows licensing procedures and a check of these systems to confirm windows is properly activated is required.

Device

STATION UPGRADE
  • Modèle / numéro de série
    Model Catalog: 23CUP003CVX720 (Lot serial: 200909); Model Catalog: 23CUP001CVX720 (Lot serial: 200909); Model Catalog: 23CUP005CVMV4 (Lot serial: 200911); Model Catalog: 23CUP003CVX720 (Lot serial: 200911); Model Catalog: 23CUP001CVX720 (Lot serial: 200911); Model Catalog: 23CUP005CVMV4 (Lot serial: 200913); Model Catalog: 23CUP003CVX720 (Lot serial: 200913); Model Catalog: 23CUP001CVX720 (Lot serial: 200913); Model Catalog: 23CUP005CVMV4 (Lot serial: 200914); Model Catalog: 23CUP003CVX720 (Lot serial: 200914); Model Catalog: 23CUP001CVX720 (Lot serial: 200914); Model Catalog: 23CUP005CVMV4 (Lot serial: 201047); Model Catalog: 23CUP003CVX720 (Lot serial: 201047); Model Catalog: 23CUP001CVX720 (Lot serial: 201047); Model Catalog: 23CUP005CVMV4 (Lot serial: 200902); Model Catalog: 23CUP003CVX720 (Lot serial: 200902); Model Catalog: 23CUP001CVX720 (Lot serial: 200902); Model Catalog: 23CUP005CVMV4 (Lot serial: 200903); Model Catalog: 23CUP003CVX720 (Lot serial: 200903); Model Catalog: 23CUP001CVX720 (Lot serial
  • Description du dispositif
    STATION UPGRADE;CYTOVISION STATION XP TO WIN7 UPGRADE;K/F STATION
  • Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.

Manufacturer

LEICA BIOSYSTEMS RICHMOND INC.