Computed tomography x-ray systems with software syngo — Class II medical device recall Z-2500-2021
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-09-29, distributed nationwide. Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user
| Recall number | Z-2500-2021 |
|---|---|
| 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 | 2021-08-18 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 31 units |
| Reason classes | software |
| Serial numbers | 108062, 108088, 108108, 108111, 108158, 111219, 111307, 111427, 111507, 111518, 111526, 111560, 111566, 117533, 117558, 117633, 117647, 119142, 119317, 119328, 119376, 123054, 123055, 123059, 123060 and 6 more |
| Model numbers | 11061610, 11061612, 11061613, 11061618, 11061620, 11061622, 11061623, 11061628, 11061630, 11061632, 11061638, 11061640, 11061642, 11061648, 11061660, 11061668, 11061670, 11061678, 11330001 |
Product
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Reason for recall
Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan 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-2500-2021. 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.