Carestream Health, Inc. recalls CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digita…

Recall date

January 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1377-2015

FDA classification

Class II

Brand / firm

Carestream Health, Inc.

Sold / distributed

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.

Why it was recalled

Units device head descended unexpectedly

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.