FDA-Device2016-07-27Class II

Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

Siemens Medical Solutions USA, Inc
Hazard

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

Sold states
Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.
Affected count
50 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2245-2016

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