Events

Retiro De Equipo (Recall) de Device Recall OEC 8800 Flexview,

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 OEC Medical Systems, Inc.

¿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
    62387
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2065-2012
  • Fecha de inicio del evento
    2006-11-20
  • Fecha de publicación del evento
    2012-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110394
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Causa
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being classified by the agency. the oec 8800 flexview was recalled in november 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod.
  • Acción
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8.

Device

Device Recall OEC 8800 Flexview,
  • Modelo / Serial
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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system || Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Dirección del fabricante
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA