ARTIS pheno- angiography systems developed for single and biplane… — Class II medical device recall Z-2029-2021
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-07-14, distributed nationwide. Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped perip
| Recall number | Z-2029-2021 |
|---|---|
| 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 | 2021-05-27 |
| Classified | 2021-07-07 |
| Reported by FDA | 2021-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 116 units |
| Reason classes | software |
| Serial numbers | 164013, 164018, 164019, 164021, 164022, 164024, 164025, 164026, 164027, 164028, 164033, 164034, 164049, 164053, 164054, 164055, 164057, 164060, 164061, 164063, 164064, 164066, 164068, 164069, 164071 and 91 more |
| Model numbers | 10849000 |
Product
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reason for recall
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
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-2029-2021. 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.