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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 May 25, 2017
Date Posted June 19, 2017
Recall Status1 Terminated 3 on June 13, 2018
Recall Number Z-2651-2017
Recall Event ID 77250
510(K)Number K120062  
Product Classification System, x-ray, mobile - Product Code IZL
Product DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution ---
The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Code Information Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482
Recalling Firm/
Manufacturer		 Carestream Health Inc
150 Verona St
Rochester NY 14608-1733
For Additional Information Contact Customer Care Center
800-328-2910
Manufacturer Reason
for Recall		 Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
FDA Determined
Cause 2		 Process control
Action Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.
Quantity in Commerce Domestic: 1449 units; Foreign: 1416 units
Distribution Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.
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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