Recall Z-1378-2015 ยท MUH System, X-Ray, Extraoral Source, Digital
Carestream Health, Inc.
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.
| Date | Apr 3, 2015 (initiated Jan 8, 2015) |
| Status | Terminated |
| Reason | Units device head descended unexpectedly |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 470 units (127 domestically & 343 internationally) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133406 | CS 8100 3D Trophy, Mar 14, 2014 |