FDA Device recall Z-2688-2020
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2688-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-24 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Reason
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.
Identifiers
| code_info | syngo.via VB30 or VB40: All Lots Model #: 10496180 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2688-2020%22
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