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U.S. Department of Health and Human Services

Class 2 Device Recall EOS Imaging

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  Class 2 Device Recall EOS Imaging see related information
Date Initiated by Firm November 29, 2013
Date Posted December 26, 2013
Recall Status1 Terminated 3 on January 13, 2015
Recall Number Z-0580-2014
Recall Event ID 66980
510(K)Number K130395  
Product Classification System, image processing, radiological - Product Code LLZ
Product steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images

Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Code Information Software versions: 1.3, 1.4 and 1.5
Recalling Firm/
Manufacturer		 EOS Imaging
10 rue Mercoeur 4 Ieme Etage
Paris France France
Manufacturer Reason
for Recall		 Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
FDA Determined
Cause 2		 Software design
Action EOS imaging issued a safety information letter dated November 29, 2013, to the US customer sites. The letter identifed the affected product, problem and actions to be taken. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. The letter informed customers that EOS imaging will, at it's own expense, corect all systems affected by means of a software update. An EOS imaging representative will contact affected customers to make an appointment for this update once it is available. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. For questions call +33 (0) 155 25 6060.
Quantity in Commerce 36 units
Distribution USA Nationwide Distribution
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 = LLZ and Original Applicant = EOS IMAGING INC.
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