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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62678
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
syngo Imaging XS. Radiological image processing system. Model number 10496279 Class II There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms". 52 Z-2264-2012