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U.S. Department of Health and Human Services

Class 2 Device Recall EOS Imaging

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 Class 2 Recall
EOS Imaging
see related information
Date Posted December 26, 2013
Recall Status1 Open
Recall Number Z-0580-2014
Recall Event ID 66980
Premarket Notification
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
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
DESIGN: 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 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 = LLZ and Original Applicant = EOS IMAGING INC.
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