Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 7/29/2020
Syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Recall Number: Z-2688-2020
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 occurrence of this issue is very unlikely and has never been reported so far.
Siemens Medical Solutions USA, Inc on 6/24/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE