Events

Retiro De Equipo (Recall) de MR APPLICATIONS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    17414
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-08-19
  • 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
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode) magnitude weighting mask is always on and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

MR APPLICATIONS
  • Modelo / Serial
    Model Catalog: 5434388-X (Lot serial: 00000L0240862D); Model Catalog: 5434388-X (Lot serial: 00000287170GE5); Model Catalog: 5434388-X (Lot serial: 00000287171GE3); Model Catalog: 5434388-X (Lot serial: 00000322015GE9); Model Catalog: 5434388-X (Lot serial: 00000328735GE6); Model Catalog: 5434388-X (Lot serial: 00000281269GE1)
  • Descripción del producto
    CARDIACVX
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)