Events

Retiro De Equipo (Recall) de GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ

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
    64884
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1142-2013
  • Fecha de inicio del evento
    2011-10-21
  • Fecha de publicación del evento
    2013-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117259
  • 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
    As part of ge innova iq table introduction, a label was designed to be affixed on the front cover of the gantry pivot section. this safety label is missing on systems manufactured between march 2010 and july 2011. in the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the c-arm gantry pivot and the head section of the table, there is a risk of co.
  • Acción
    A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued. For further questions please call (262) 513-4122.

Device

GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ
  • Modelo / Serial
    Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.
  • Descripción del producto
    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, || Cardiovascular and Interventional Imaging System.
  • 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