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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 66980
Product Type Devices
Status Ongoing
Recalling Firm EOS Imaging
City Paris France
Country FR
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-29
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Software versions: 1.3, 1.4 and 1.5 Class II Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation 36 units Z-0580-2014