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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 Systemsee related information
Date Initiated by FirmMay 25, 2017
Date PostedJune 19, 2017
Recall Status1 Terminated 3 on June 13, 2018
Recall NumberZ-2651-2017
Recall Event ID 77250
510(K)NumberK120062 
Product Classification System, x-ray, mobile - Product Code IZL
ProductDRX-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 ContactCustomer 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
ActionCarestream 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 CommerceDomestic: 1449 units; Foreign: 1416 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = IZL
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