Monday, April 20, 2015

Carestream CS 8100 3D Undergoes FDA Recall

Carestream 8100 3D.jpeg
Something owners & buyers should be aware of.  It seems the Carestream 8100 3D cone beam device is undergoing an FDA recall.  
Here is the info:
Date PostedApril 03, 2015
Recall Status1Open
Recall NumberZ-1378-2015
Recall Event ID70649
Premarket Notification
510(K) Number
Product ClassificationSystem,X-Ray,Extraoral Source,Digital - Product CodeMUH
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 InformationAll serial numbers of affected devices.
Recalling Firm/
Carestream Health, Inc.
1049 W Ridge Rd
Rochester, New York 14615-2731
Manufacturer Reason
for Recall
Units device head descended unexpectedly
FDA Determined
Cause 2
DESIGN: 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

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