Reported Jul 29, 2020 · Terminated
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
- Lot codes and dates
- syngo
- via VB30 or VB40All Lots Model #: 10496180
- Amount recalled
- 21 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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