Events

Retiro De Equipo (Recall) de IMPAX FOR CARDIOLOGY - CLINICAL REVIEW STATION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AGFA HEALTHCARE 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
    32449
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-27
  • 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
    Echocardiography volume measurements that were performed within crs were not reflected correctly in associated results management (rm) reports. this occurred when echocardiography volume measurement data was not saved correctly within the crs persistence data and in the rm database. the issue was caused when point-trace mode was enabled in crs a feature that was introduced in crs 2.12.05. a software upgrade to crs 2.14.03.Su2 will be made.

Device

IMPAX FOR CARDIOLOGY - CLINICAL REVIEW STATION
  • Modelo / Serial
    Model Catalog: 60+00007792 (Lot serial: )
  • Descripción del producto
    CARDIOVASCULAR REVIEW STATION
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Source
    HC