Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CS 8100 3D Recalled by Carestream Health, Inc. Due to Units device head descended unexpectedly
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Carestream Health, Inc. directly.
Affected 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.
Quantity: 470 units (127 domestically & 343 internationally)
Why Was This Recalled?
Units device head descended unexpectedly
Where Was This Sold?
This product was distributed to 46 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Carestream Health, Inc.
Carestream Health, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report