FDA-Device2014-05-21Class II
Syngo Dynamics v9.5 system. 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.
Siemens Medical Solutions USA, Inc
Hazard
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Sold states
US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
Affected count
50
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Syngo Dynamics v9.5 system. 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2014Don't want to check this manually?
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