Events

Retiro De Equipo (Recall) de GE Advantx and Innova Cardiovascular X-ray System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Medical Systems SCS.

¿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
    15260
  • Fecha de inicio del evento
    2013-08-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The manufacturer has identified the potential for the 4 outer screws that hold the overhead video monitor suspension to the carriage to be missing. missing screws may increase the risk for fall of the monitor suspension.
  • Acción
    Product to be modified

Device

GE Advantx and Innova Cardiovascular X-ray System
  • Modelo / Serial
    Model: Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ, Affected: Systems equiped with video monitor suspension
  • Manufacturer
    GE Medical Systems SCS

Manufacturer

GE Medical Systems SCS