Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov

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 Healthcare, 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
    65029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1318-2013
  • Fecha de inicio del evento
    2011-12-20
  • Fecha de publicación del evento
    2013-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117691
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    While performing a fluoroscopic examination on the ge innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (pdb). although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
  • Acción
    GE Healthcare did not send out customer letters. GE Healthcare completed the correction by replacing the faulty relay in all affected systems. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests recorded the repair of the affected units. Exceptions to completion of the service request were recorded as well. Records of field action completion will be retained per their processes and procedures. Should you have any questions or require additional information, please call (262) 548-2757.

Device

Device Recall GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Inno...
  • Modelo / Serial
    Serial 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela
  • Descripción del producto
    GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. || For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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