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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62581
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions, USA, Inc
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
syngo Dynamics Version 9.5 10091862 and 10091863 Class II If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. 30 Z-2219-2012
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