Events

Retiro De Equipo (Recall) de RTVUE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CLARION MEDICAL TECHNOLOGIES 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
    135258
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-18
  • 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
    A minor software upgrade for optovue device families were released on february 22 2016. the device families are the ivue (rtvue - ivue100) ifusion and ivue500 (iscan in the us). the software configuration is 2016.1.0.127 (outside the us only). the device user will perform a scan of a patient's retina. they may then review the data within a series of available reports. two reports are affected by the software anomaly: (1) retina map ou report and (2) iwellness ou report. for example in the new retina map ou report the user may scroll on the map" or the "b-scan" image of either eye. this activates the software anomaly and makes both b-scans identical (i.E. - both show the same eye). whether both eyes become left or right depends on how you enter the report. for example entering the ou report from the od (right eye) report will cause both b-scans to be right eye when scrolling is attempted.

Device

RTVUE
  • Modelo / Serial
    Model Catalog: IVUE100 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    RTVUE OCT SCANNER
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.