Events

Retiro De Equipo (Recall) de GE Magnetic Resonance Imaging Systems

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 LLC.

¿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
    16485
  • Fecha de inicio del evento
    2014-04-03
  • 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
    Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the endbell. this overheating has occurred only while units were being serviced by ge service engineers during repeated evaluation scanning. however, the issue could also occur in clinical mode.
  • Acción
    Product to be modified

Device

GE Magnetic Resonance Imaging Systems
  • Modelo / Serial
    Model: Models: : Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products, Affected:
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC