Events

Retiro De Equipo (Recall) de Device Recall GE OEC 9800

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
    51222
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2038-2012
  • Fecha de inicio del evento
    2008-02-22
  • Fecha de publicación del evento
    2012-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79254
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 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 vertical lift column power supply in the mainframe c-arm of the device is defective and subject to early life failure.
  • 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. The firm, GE Healthcare, Surgery, sent an "URGENT RECALL NOTICE" dated November 8, 2006 via certified mail with return receipt request to consignees/customers with specific instructions. Customers were advised "to stop using the system WITH NAVIGATION until this replacement has been successfully completed. OEC@ FluoroTrak 9800 Plus system may be used as a standard C-Arm providing you review the other issues as listed below." GEHC OEC is actively working on solutions that will permanently resolve each of the noted issues. If you have any questions or concerns regarding these issues, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Information is available at this number 24 hours per day, 7 days a week.

Device

Device Recall GE OEC 9800
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. || The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's 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