syngo — Class II medical device recall Z-2688-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-07-29, distributed nationwide. If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard
| Recall number | Z-2688-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-06-24 |
| Classified | 2020-07-22 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| Reason classes | software |
| Model numbers | 10496180 |
Product
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2688-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.