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.
- Company
- Carestream Health, Inc.
- Recall Initiated
- January 8, 2015
- Posted
- April 3, 2015
- Terminated
- April 20, 2017
- Recall Number
- Z-1378-2015
- Quantity
- 470 units (127 domestically & 343 internationally)
- Firm Location
- Rochester, NY
Reason for Recall
Units device head descended unexpectedly
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.
Lot / Code Info
All serial numbers of affected devices.
Root Cause
Component design/selection
Action Taken
The firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.