Device Recall AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 3111668, 3111676, 8890407, 8890415, and 10093902
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
  • 제품 설명
    AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS || System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
  • Source
    USFDA