FDA-Device2015-04-15Class II
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.
Carestream Health, Inc.
Hazard
Units device head descended unexpectedly
Sold states
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.
Affected count
470 units (127 domestically & 343 internationally)
Manufactured in
1049 W Ridge Rd, N/A, Rochester, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1378-2015Don't want to check this manually?
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