FDA-Device2012-09-05Class II

syngo Imaging XS. Radiological image processing system.

Siemens Medical Solutions USA, Inc
Hazard

There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".

Sold states
Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Affected count
52
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
syngo Imaging XS. Radiological image processing system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2012

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