Device Recall CS 8100, CS 8100 Access

  • Modèle / numéro de série
    All serial numbers of affected devices.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • Société-mère du fabricant (2017)
  • Source
    USFDA