Device Recall GE Healthcare Innova IGS 540

  • 모델명 / 제조번호(시리얼번호)
    Serial Number System ID 0000012C2S0118 850862IGS 0000013C2S0207 352333VASC2 15C2R0063 GON4244211 15C2R0068 210297GE540 15C2R0053 804323IGS540 0000015C2R0059 0828160013
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
  • 제품 설명
    GE Healthcare Innova IGS 540. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA