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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 3D see related information
Date Initiated by Firm January 08, 2015
Date Posted April 03, 2015
Recall Status1 Open3, Classified
Recall Number Z-1378-2015
Recall Event ID 70649
510(K)Number K133406  
Product Classification System,x-ray,extraoral source,digital - Product Code MUH
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.
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
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 in Commerce 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.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUH and Original Applicant = TROPHY
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