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Class 2 Device Recall Carestream DRX Evolution System |
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Date Initiated by Firm |
June 03, 2013 |
Date Posted |
August 12, 2013 |
Recall Status1 |
Terminated 3 on January 29, 2014 |
Recall Number |
Z-1877-2013 |
Recall Event ID |
65369 |
510(K)Number |
K091889
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Product Classification |
System, x-ray, stationary - Product Code KPR
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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.
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Code Information |
Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software |
Recalling Firm/ Manufacturer |
Carestream Health Inc. 150 Verona St Rochester NY 14608-1733
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For Additional Information Contact |
800-328-2910
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Manufacturer Reason for Recall |
Due to potential for an x-ray exposure technique change.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = CARESTREAM HEALTH, INC.
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