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U.S. Department of Health and Human Services

Class 2 Device Recall DRXRevolution Mobile XRay System

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  Class 2 Device Recall DRXRevolution Mobile XRay System see related information
Date Initiated by Firm January 12, 2017
Create Date February 03, 2017
Recall Status1 Terminated 3 on June 13, 2018
Recall Number Z-1138-2017
Recall Event ID 76134
510(K)Number K120062  
Product Classification System, x-ray, mobile - Product Code IZL
Product Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Code Information Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)
Recalling Firm/
Manufacturer		 Carestream Health Inc
150 Verona St
Rochester NY 14608-1733
Manufacturer Reason
for Recall		 The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
FDA Determined
Cause 2		 Device Design
Action Carestream Health Inc. sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated December 29, 2016, and response forms were sent to the US customers via Certified Mail-Return Receipt Requested on January 12, and January 13, 2017, informing them of the problem. Customers are instructed to read and complete all information and return the response form within 5 working days to the following e-mail address: postmarketra@carestream.com, or fax the completed form to (585) 454-4493. UMDC Letters and Response Forms to Canadian Customers were sent the week of January 9, 2017, via courier. Field Safety Notice (FSN) Letters for the rest of world are in process. FSN Letters for the EMEA should be sent via courier starting later this week. US Carestream Customer Care Center #: 1-800-328-2910 (24/7). Outside of the US, please call your local Service support number.
Quantity in Commerce US: 1403 units; Foreign: 1370 units
Distribution Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, 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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