Events

Retiro De Equipo (Recall) de Device Recall GE Signa Advantage

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States 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
    33320
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0858-06
  • Fecha de inicio del evento
    2005-08-19
  • Fecha de publicación del evento
    2006-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41690
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Causa
    During use of ge signa nuclear magnetic resonance imaging system, a flexible teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.
  • Acción
    GE Healthcare is issuing an Urgent Safety Notification to all affected customer sites beginning 09/01/05. The notification describes the concurrent condition that must exist in order for the event to occur. Users are warned to be present at all times when scanning patients and to take emergency measures to vent the scan room should the magent quench. Beginning September 2005, all affected customers'' devices will have the Teflon venting tube replaced with a nonflexible venting tube.

Device

Device Recall GE Signa Advantage
  • Modelo / Serial
    All GE Signa Advantage MRI magnets with the model numbers 46-260805G1, 46-260805G2, 46-281380G1, 46-281380G2, 46-281380G3, 46-281380G4, 46-281380G5, 46-281380G6, 46-281380G7 and 46-281380G8
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and to countries OUS including: United Arab Emirates, Argentina, Australia, Brazil, Canada, China, Germany, Denmark, Egypt, Spain, France, United Kingdom, Ireland, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, Saudi Arabia, Sweden, Turkey and Tiawan
  • Descripción del producto
    GE Signa Advantage nuclear magnetic resonance imaging system.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA