Events

Retiro De Equipo (Recall) de INNOVA 4100IQ - MAIN UNIT

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
    101168
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-02-07
  • 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
    Innova operator manual states that the air kerma ratio between the "low" and "normal" mode of operation during fluoroscopy exposure shall remain below 50% of normal detail mode forfluoroscopy. ge healthcare became aware of a potential issue on a specific fluoro mode setting rdl (auto-exposure preference) for which the "low" to "normal" dose rate ratio might be higher than 50% at very low dose level (6.7 mgy/min versus limit at 43.8 mgy/min) with 7.5 fps and 15 fps. as a result this issue raised a regulatory non-conformance concern. ge healthcare has completed upgrades to all affected units through software field actions thereby correcting the issue.

Device

INNOVA 4100IQ - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)