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Siemens Medical Solutions USA, Inc recalls Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Recalled May 11, 2016 · FDA recall Z-1601-2016 · Siemens Medical Solutions USA
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. · FDA Class II
Units
84 units
Sold at
Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
Description
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.
Product
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →