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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS)

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  Class 2 Device Recall Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS) see related information
Date Initiated by Firm November 25, 2013
Date Posted January 21, 2014
Recall Status1 Terminated 3 on June 30, 2016
Recall Number Z-0796-2014
Recall Event ID 67047
510(K)Number K091889  
Product Classification System, x-ray, mobile - Product Code IZL
Product DRX-Evolution with FF WS

These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Code Information Service Code: 7171
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1049 Ridge Rd W
Rochester NY 14615-2731
For Additional Information Contact
585-781-1997
Manufacturer Reason
for Recall		 Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Carestream Health Inc, sent an "URGENT: Medical Device Recall" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of the E-stop button for customers using the FF WS. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
Quantity in Commerce 675 units Total (145 units domestically & 530 units internationally)
Distribution Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = CARESTREAM HEALTH, INC.
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