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
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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
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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 |
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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 = LLZ
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