SOMATOM Definition AS-Computed tomography system Model 8098027 — Class II medical device recall Z-0473-2022
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-0473-2022 |
|---|---|
| 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 | 794 units |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 04056869003665 |
| Serial numbers | 156012, 156018, 59802, 59803, 59812, 59814, 59815, 59819, 59820, 59822, 59823, 59824, 59825, 59828, 59829, 64019, 64022, 64030, 64031, 64036, 64051, 64052, 64056, 64060, 64064 and 475 more |
| Model numbers | 8098027 |
Product
SOMATOM Definition AS-Computed tomography system Model 8098027
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-0473-2022. 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.