Device Recall OEC 9900 Elite

Fabricante

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

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. || The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
  • Manufacturer
  • Modelo / Serial
    Model Numbers - OEC 9900 Elite
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
  • Descripción del producto
    The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. || Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
  • Manufacturer
  • Modelo / Serial
    Serial Numbers: E2-0019, E2-0028, E2-0064, E2-0142, E2-0156, E2-0170, E2-0180, E2-0213, E9-0008, E9-0040-G, E9-0103, E9-0029, ES-0060, ES-0088, ES-0096, ES-0099, E9-0150, E9-0152, E9-0158.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Germany.
  • Descripción del producto
    OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
  • Modelo / Serial
    Serial Numbers: E2-7075-MH, ES-0029-CH, ES-0046-CH, ES-0066-CH, ES-0131-H.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Germany.
  • Descripción del producto
    OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer