Events

Retiro De Equipo (Recall) de STATION UPGRADE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA BIOSYSTEMS RICHMOND INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    33127
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / 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
  • Descripción del producto
    STATION UPGRADE;CYTOVISION STATION XP TO WIN7 UPGRADE;K/F STATION
  • Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.

Manufacturer

LEICA BIOSYSTEMS RICHMOND INC.