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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream DRX Evolution System

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 Class 2 Recall
Carestream DRX Evolution System
see related information
Date Posted August 12, 2013
Recall Status1 Terminated on January 29, 2014
Recall Number Z-1877-2013
Recall Event ID 65369
Premarket Notification
510(K) Number
K091889 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Code Information Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software
Recalling Firm/
Manufacturer
Carestream Health Inc.
150 Verona St
Rochester, New York 14608-1733
Manufacturer Reason
for Recall
Due to potential for an x-ray exposure technique change.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. Carestream Health will contact the customer to schedule a service visit to install software updates to correct this issue. The installation time will be approximately one hour. 3. As stated in the customer notification letter, this software update will be provided to the customer at no expense. 4. All software updates are estimated to be completed within 1-3 months. 5. Carestream Health will provide monthly progress reports on the effectiveness of the plan, including the number of units corrected. Further questions please call (800) 328-2910.
Quantity in Commerce US: 49 units; Foreign: 183 units (revised)
Distribution Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, 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 = KPR and Original Applicant = CARESTREAM HEALTH, INC.
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