Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/21/2014
Class lI:
PRODUCT
Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. Recall Number Z-1613-2014
REASON
Siemens Medical Solutions USA, Inc. has become aware of a potential issue with the Syngo Dynamics v9.5 system with a specific set of serial numbers. Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 4/3/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
50
DISTRIBUTION
Nationwide
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