FDA-Device2016-05-11Class II
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Siemens Medical Solutions USA, Inc
Hazard
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
Sold states
Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
Affected count
84 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1601-2016Don't want to check this manually?
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