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U.S. Department of Health and Human Services

Class 2 Device Recall DRX Revolution Mobile XRay System

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 Class 2 Recall
DRX Revolution Mobile XRay System
see related information
Date Posted October 31, 2013
Recall Status1 Open
Recall Number Z-0090-2014
Recall Event ID 65805
Premarket Notification
510(K) Number
K120062 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Code Information Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218
Recalling Firm/
Manufacturer
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608-1733
Manufacturer Reason
for Recall
During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.
FDA Determined
Cause 2
DESIGN: Software Design
Action Carestream sent a Urgent-Medical Device Recall letter dated July 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Carestream Health Inc. recently discovered an image artifact issue due to a detector not being recalibrated with the 5.6B software upgrade. As our installation instructions did not require the user to recalibrate during an upgrade, there is a possibility your detector could do the same. When this occurs an image artifact could be evident on images captured in the Extended Exposure mode. These artifacts could potentially contribute to misdiagnosis or the necessity of patient re-exposure. We request that you take a moment to verify that your detector(s) are calibrated. At our next visit, Carestream will also verify that your detector was re-calibrated and, if not, re-calibrate the detector for you. Please note this only affects systems upgraded in the field. For questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910, 8 am through 8 pm EST in the US.
Quantity in Commerce 23 units installed total (11 domestically & 12 internationally)
Distribution Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = CARESTREAM HEALTH, INC.
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