FDA-Device2016-03-02Class II
software for Syngo Dynamics 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.
Siemens Medical Solutions USA, Inc
Hazard
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
Sold states
US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
Affected count
151
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
software for Syngo Dynamics 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2016Don't want to check this manually?
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