Events

Retiro De Equipo (Recall) de IMAGE PASTING PATIENT BARRIER

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
    132271
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-10-19
  • 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
    Ge healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and/or user safety. the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. this could permit the arm to swing freely when the rotating arm locking lever is released. should this happen during use injury to the patient and/or user could occur.

Device

IMAGE PASTING PATIENT BARRIER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)