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U.S. Department of Health and Human Services

Class 2 Device Recall CS 8100 3D

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 Class 2 Device Recall CS 8100 3Dsee related information
Date Initiated by FirmJanuary 08, 2015
Date PostedApril 03, 2015
Recall Status1 Terminated 3 on April 20, 2017
Recall NumberZ-1378-2015
Recall Event ID 70649
510(K)NumberK133406 
Product Classification System,x-ray,extraoral source,digital - Product Code MUH
ProductCS 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.
Code Information All serial numbers of affected devices.
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
For Additional Information Contact
585-781-1997
Manufacturer Reason
for Recall		Units device head descended unexpectedly
FDA Determined
Cause 2		Component design/selection
ActionThe 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 in Commerce470 units (127 domestically & 343 internationally)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUH
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