SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go — Class II medical device recall Z-0962-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-04-27, distributed nationwide. Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifi
| Recall number | Z-0962-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-03-07 |
| Classified | 2022-04-20 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 547 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869051291, 04056869051307, 04056869051314, 04056869051321, 04056869151564, 04056869151571, 04056869151588, 04056869151595, 04056869231044, 04056869239736, 04056869239743, 04056869249230, 04056869249247 |
| Serial numbers | 106115, 106133, 106237, 106260, 106360, 106400, 106459, 106464, 106484, 106526, 106527, 106545, 106562, 108054, 108056, 108062, 108076, 108080, 108085, 108088, 108095, 108099, 108101, 108106, 108108 and 475 more |
Product
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
Reason for recall
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and 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-0962-2022. 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.