Events

Retiro De Equipo (Recall) de PRECISION 500D SYSTEM - FLURO CARRAGE & TOWER

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
    27344
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-12-24
  • 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
    It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that your system has not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension. however missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue. missing screws may increase the risk for the monitor to fall.

Device

PRECISION 500D SYSTEM - FLURO CARRAGE & TOWER
  • Modelo / Serial
    Model Catalog: S0910ZC (Lot serial: n/a); Model Catalog: S0912PB (Lot serial: n/a); Model Catalog: S14501BT (Lot serial: n/a); Model Catalog: S13001AX (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a)
  • Descripción del producto
    PRECISION 500D SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)