Events

Recall of STATION UPGRADE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS RICHMOND INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33127
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Product Description
    STATION UPGRADE;CYTOVISION STATION XP TO WIN7 UPGRADE;K/F STATION
  • Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.

Manufacturer

LEICA BIOSYSTEMS RICHMOND INC.