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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Event Detail

Event ID 63521
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 2012-06-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System Model number 10 592 457 Class II Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could remain unprotected and not archived leading to a potential data loss. - System crashes when user tries to delete a self created spine labeling step. - For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user. - 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. - Viewer crashes during load of next patient. Error is related to 'Next Patient' from RIS. 15 Z-0465-2013