syngo — Class II medical device recall Z-0995-2022
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2022-05-04, distributed nationwide. Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow"
| Recall number | Z-0995-2022 |
|---|---|
| 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 | 2022-03-07 |
| Classified | 2022-04-22 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2023-12-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BH, BR, CH, CZ, DE, DK, ES, FR, GB, HU, IN, IT, JP, NL, NO, PL, RO, SK |
| Quantity | 1 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869051314 |
| Serial numbers | 112261 |
| Model numbers | 11061620 |
Product
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reason for recall
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
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-0995-2022. 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.