FDA Device recall Z-1378-2015
CS 8100 3D, CATALOG # (s): 5311162, 5311188
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of CS 8100 3D, CATALOG # (s): 5311162, 5311188 by Carestream Health, citing units device head descended unexpectedly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1378-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-08 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV |
Product
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.
Reason
Units device head descended unexpectedly
Identifiers
| code_info | All serial numbers of affected devices. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1378-2015%22
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