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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description Siemens syngo.plaza radiological image processing system.
Recall Number Z-0048-2013
Classification Class II
Code Info Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
Product Distributed Qty 11
Reason For Recall Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

Event Detail

Event Id 63045
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 2012-06-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.