Events

Retiro De Equipo (Recall) de INNOVA 4100IQ - MAIN UNIT

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
    151363
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-06-02
  • 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
    Jnexpected system lockups may occur while using the image auto-archiving function. if it occurs during x-ray imaging the acquisition fails and the user has to reset the system.

Device

INNOVA 4100IQ - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 2335129 (Lot serial: MANUFACTURER); Model Catalog: 2335139-2 (Lot serial: MANUFACTURER); Model Catalog: S18741AM (Lot serial: CONTACT); Model Catalog: 2335139-2 (Lot serial: CONTACT); Model Catalog: S18741AM (Lot serial: >10 NUMBERS); Model Catalog: 2335129 (Lot serial: >10 NUMBERS); Model Catalog: 2335139-2 (Lot serial: >10 NUMBERS); Model Catalog: S18741AM (Lot serial: MANUFACTURER); Model Catalog: 2335129 (Lot serial: CONTACT); Model Catalog: 2335139-4 (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: S18751AP (Lot serial: 498683BU2 7C20329 520071BU2); Model Catalog: 2335139-4 (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: 2335139-4 (Lot serial: 498683BU2 7C20329 520071BU2)
  • Descripción del producto
    INNOVA 4100 IQ - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)