Siemens recalls syngo.via RT Image Suite software versions VB30/VB40 due to rare image orientation errors that could lead to incorrect radiation treatment plans if not noticed.
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.
Siemens is recalling syngo.via RT Image Suite software versions VB30 and VB40. This recall is because users modifying image orientation for synthetic CT processing might create images with wrong geometry, which could lead to incorrect radiation treatment plans if the error goes unnoticed. The risk is very unlikely and has never been reported.
If users change the original image orientation of standard MRI scans for synthetic CT processing, the software may not recognize the new orientation. This can cause images with incorrect geometry. If these distorted images are used in treatment planning without noticing the error, radiation treatment plans could be incorrect.
Medical professionals using Siemens syngo.via RT Image Suite software versions VB30 or VB40 for radiation treatment planning. Those most at risk are users who modify image orientations for synthetic CT processing.
Check if you have Siemens syngo.via RT Image Suite software versions VB30 or VB40. The model number for these versions is 10496180.
Verify your software version by checking the model number on the device or software settings.
The recall states the issue is very unlikely and has never been reported, so the risk is low.
Check if your software version is syngo.via VB30 or VB40 with model number 10496180.
No action is required as the issue is very unlikely and has never been reported.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2688-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2688-2020 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
