Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 |
| Quantity | 116 units |
| Distribution | US Nationwide |
| Initiated | 2021-05-27 |
| Classified | 2021-07-07 |
| Recall number | Z-2029-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-2029-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88216/
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