Events

Retiro De Equipo (Recall) de SIGNA PIONEER

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
    81008
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-23
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 60903. images may exhibit novel artifacts on magic t2 flair synthetic reconstructions that may be difficult to recognize without access to conventional t2 flair weighted images. this issue has the potential to lead to misinterpretation of the magic images when making medical diagnosis or treatment decisions. magic acquisition is unique in that all contrasts are acquired simultaneously therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artifacts. there have been no injuries reported as a result of this issue.

Device

SIGNA PIONEER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)