SOMATOM Definition Edge -Computed tomography system Model 10590000 — Class II medical device recall Z-0475-2022
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-0475-2022 |
|---|---|
| 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) |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 04056869006949 |
| Serial numbers | 155300, 155304, 155309, 155312, 155315, 155316, 155318, 155322, 155328, 155329, 155335, 155341, 155342, 155343, 155348, 155350, 155351, 155353, 155354, 155356, 155357, 155358, 155360, 155361, 155364 and 311 more |
| Model numbers | 10590000 |
Product
SOMATOM Definition Edge -Computed tomography system Model 10590000
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-0475-2022. 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.