Z-1378-2015 Class II Terminated
FDA device recall Z-1378-2015 was initiated by Carestream Health, Inc. on January 8, 2015 and is designated Class II. Reason for recall: Units device head descended unexpectedly The recall status is terminated (terminated April 20, 2017). Affected quantity: 470 units (127 domestically & 343 internationally).
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- January 8, 2015
- Termination Date
- April 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 470 units (127 domestically & 343 internationally)
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.
Reason for Recall
Units device head descended unexpectedly
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.
Code Information
All serial numbers of affected devices.