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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description syngo Dynamics Version 9.5
Recall Number Z-2219-2012
Classification Class II
Code Info 10091862 and 10091863
Product Distributed Qty 30
Reason For Recall 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.

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.