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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description 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.
Recall Number Z-0580-2014
Classification Class II
Code Info Software versions: 1.3, 1.4 and 1.5
Product Distributed Qty 36 units
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

Event Detail

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