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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 Device Recall DRX Revolution Mobile Xray System see related information
Date Initiated by Firm August 29, 2013
Date Posted November 07, 2013
Recall Status1 Terminated 3 on June 28, 2016
Recall Number Z-0179-2014
Recall Event ID 66067
510(K)Number K120062  
Product Classification System, x-ray, mobile - Product Code IZL
Product DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608

to perform radiographic x-ray examinations on all pediatric and adult patients
Code Information Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
Recalling Firm/
Manufacturer		 Carestream Health Inc.
150 Verona St
Rochester NY 14608-1733
For Additional Information Contact
800-328-2910
Manufacturer Reason
for Recall		 Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
FDA Determined
Cause 2		 Software design
Action The firm, Carestream Health Inc., sent an "Urgent: Medical Device Recall" letter dated August 29, 2013 to its customers. The letter described the product, problem and actions taken. Carestream has developed a software patch that will allow Normal Exposure Mode and Extended Exposure Mode images to be taken in any order and will install the patch in all DRX-Revolution, DRC-Mobile and DRX-Transportable Systems with software version 5.5 or higher and Detector firmware version 69 or higher. No DRX Transportables were affected. Your Carestream service representative will install the patch at your next service call. If you have questions or concerns, or if you experience an issue prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8am through 8pm Eastern Standard Time.
Quantity in Commerce 190 units
Distribution Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.
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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