Events

Retiro De Equipo (Recall) de SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VANTAGE ENDOSCOPY 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
    15176
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-07
  • 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
    Changes to the instructions for the leak test method specified for all fujifilm endoscopes in the cleaning disinfection and storage operation manuals as well as the operation manuals for the air leak tester lt-7f were made to ensure consistency with the iso 8600-7 standard. specific requirements added were to conduct the submersion test for the duration of at least one minute and using a water temperature range of 10 degrees celsius to 40 degrees celsius.

Device

SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
  • Modelo / Serial
    Model Catalog: ALL (Lot serial: ALL)
  • Descripción del producto
    SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE;SIGMOIDSCOPE;COLONOSCOPE EC;SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - BRONCHOSCOPE;DOUBLE BALLOON METHOD ELECTRONIC ENTEROSCOPY SYSTEM - ENTEROSCOPE;SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYST
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

VANTAGE ENDOSCOPY INC.
  • Dirección del fabricante
    KITCHENER
  • Empresa matriz del fabricante (2017)
    Diploma Plc
  • Source
    HC