Device Recall CS 8100 3D

  • 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 3D, CATALOG # (s): 5311162, 5311188. || Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals 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