FDA-Device2020-07-29Class II

syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Siemens Medical Solutions USA, Inc
Hazard

If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.

Sold states
US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.
Affected count
21 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2688-2020

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