Carestream Health, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1378-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 8, 2015

Date Posted: April 15, 2015

Recall Number: Z-1378-2015

Event ID: 70649

Reason for Recall:

Units device head descended unexpectedly

Status: Terminated

Product Quantity: 470 units (127 domestically & 343 internationally)

Code Information:

All serial numbers of affected devices.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated