Device Recall CS 8100, CS 8100 Access

  • Model / Serial
    All serial numbers of affected devices.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • Manufacturer Parent Company (2017)
  • Source
    USFDA