FDA-Device2016-03-23Class II
Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
Siemens Medical Solutions USA, Inc
Hazard
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
Sold states
US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.
Affected count
228 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2016Don't want to check this manually?
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