SOMATOM Confidence with software syngo — Class II medical device recall Z-0288-2022
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-12-01, distributed nationwide. software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, o
| Recall number | Z-0288-2022 |
|---|---|
| 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 | 2021-08-30 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Terminated | 2024-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 104 units |
| Reason classes | software |
| Serial numbers | 100016, 100018, 100019, 100022, 100025, 100043, 100049, 100053, 100055, 100056, 100058, 100059, 100062, 100067, 100070, 100072, 100073, 100079, 100085, 100087, 100090, 100091, 100092, 100097, 100099 and 79 more |
| Model numbers | 10590100 |
Product
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
Reason for recall
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
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-0288-2022. 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.