Device Recall OEC 9900 Elite

  • Model / Serial
    Model Numbers - OEC 9900 Elite
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    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
  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Germany.
  • Product Description
    OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
  • Model / Serial
    Serial Numbers: E2-7075-MH, ES-0029-CH, ES-0046-CH, ES-0066-CH, ES-0131-H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Germany.
  • Product Description
    OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
  • Model / Serial
    Serial # ES-0152.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Germany.
  • Product Description
    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer