Device Recall CS 8100, CS 8100 Access

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers of affected devices.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NV, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and the countries of India and Switzerland.
  • 제품 설명
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 || Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • 제조사 모회사 (2017)
  • Source
    USFDA