medical Class II Updated 2020-07-29

Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite with software versions syngo.via V

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: syngo.via VB30 or VB40: All Lots Model #: 10496180
View official government recall

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