SOMATOM Edge Plus-Computed tomography system Model 1026700 — Class II medical device recall Z-0474-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-01-19, distributed nationwide. Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patient
| Recall number | Z-0474-2022 |
|---|---|
| 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 | 2021-11-19 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 80 units |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 04056869006949 |
| Serial numbers | 122004, 122008, 122009, 122011, 122020, 122022, 122029, 122034, 122035, 122036, 122037, 122038, 122041, 122044, 122049, 122050, 122051, 122052, 122054, 122057, 122061, 122062, 122063, 122064, 122066 and 55 more |
| Model numbers | 1026700 |
Product
SOMATOM Edge Plus-Computed tomography system Model 1026700
Reason for recall
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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-0474-2022. 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.