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Carestream Health, Inc. recalls CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digi
Recalled April 15, 2015 · FDA recall Z-1377-2015 · Carestream Health
Hazard
Units device head descended unexpectedly · FDA Class II
Units
3,110 units (863 domestically & 2,247 internationally)
Sold at
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
Units device head descended unexpectedly
Product
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(s)
Carestream Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →