Events

Retiro De Equipo (Recall) de OEC MOBILE ELITE C-ARMS GENERAL SURGICAL PLATFORM NON-MOTORIZED COOLING

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
    77427
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-20
  • 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 recently become aware of a potential safety issue with the workstation power cable assembly that can result in a loss of imaging functionality due to intermittent power cord failures.

Device

OEC MOBILE ELITE C-ARMS GENERAL SURGICAL PLATFORM NON-MOTORIZED COOLING
  • Modelo / Serial
    Model Catalog: S2024DT (Lot serial: E2XXXX05722); Model Catalog: S2024DW (Lot serial: E2XXXX05722); Model Catalog: S2024DW (Lot serial: E2XXXX05472); Model Catalog: S2024DT (Lot serial: E2XXXX05472); Model Catalog: S2024DY (Lot serial: E2-5346); Model Catalog: S2024DW (Lot serial: E2-5346); Model Catalog: S2024DT (Lot serial: E2-5346); Model Catalog: S2024DY (Lot serial: E2-3338); Model Catalog: S2024DW (Lot serial: E2-3338); Model Catalog: S2024DT (Lot serial: E2-3338); Model Catalog: S2024DY (Lot serial: E2-2491); Model Catalog: S2024DW (Lot serial: E2-2491); Model Catalog: S2024DT (Lot serial: E2-2491); Model Catalog: S2024DY (Lot serial: 10173818); Model Catalog: S2024DW (Lot serial: 10173818); Model Catalog: S2024DT (Lot serial: 10173818); Model Catalog: S2024DY (Lot serial: ES-3782); Model Catalog: S2024DW (Lot serial: ES-3782); Model Catalog: S2024DT (Lot serial: ES-3782); Model Catalog: S2024DY (Lot serial: ES-3781); Model Catalog: S2024DW (Lot serial: ES-3781); Model Catalog: S2024DT (Lot serial: ES
  • Descripción del producto
    OEC 9900 ELITE (MOBILE FLUOROSCOPY C-ARMS);OEC 9800 PLUS MOBILE DIGITAL IMAGING SYSTEM - C-ARM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)