Events

Retiro De Equipo (Recall) de MR SURGICAL SUITE II TABLE

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
    44985
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-29
  • 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
    Potential safety issue with the table transfer release of the mr surgical suite ii mr system. the issue may cause an unexpected function loss of the patient transfer mechanism that allows the patient to be moved between the mr and surgical tables. this could delay care and handling of a patient during surgical or interventional procedures. ge has received one complaint of a transfer board not releasing from the mr table preventing the transfer board from moving to the surgical table. there have been no injuries reported as a result of this issue.

Device

MR SURGICAL SUITE II TABLE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)