Siemens Medical Solutions USA, Inc syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available.