Device Recall OEC 9900 Elite

  • 모델명 / 제조번호(시리얼번호)
    Serial # ES-0152.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Germany.
  • 제품 설명
    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers - OEC 9900 Elite
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Germany.
  • 제품 설명
    OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: E2-7075-MH, ES-0029-CH, ES-0046-CH, ES-0066-CH, ES-0131-H.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Germany.
  • 제품 설명
    OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer