Software versions syngo — Class II medical device recall Z-3025-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-10-07, distributed nationwide. Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user
| Recall number | Z-3025-2020 |
|---|---|
| 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 | 2020-06-22 |
| Classified | 2020-09-28 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 767 distributed |
| Reason classes | software |
| Serial numbers | 100016, 100018, 100019, 100022, 100025, 100043, 100046, 100049, 100053, 100055, 100056, 100058, 100059, 100067, 100073, 100079, 100087, 100090, 100091, 100092, 100097, 100099, 100107, 100112, 100117 and 475 more |
| Model numbers | 10267000, 10430603, 10431700, 10590000, 10590100, 10742326, 8098027 |
Product
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
Reason for recall
Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan
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-3025-2020. 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.