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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64376
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 2012-11-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Somatom CT's equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. Model numbers - 7740769, 8098027, 10430603, and 10590000. Class II Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality. 896 Z-0948-2013