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 | Terminated |
| Reason | In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator. |
| Product | ARTIS Q, Interventional Fluroscopic x-ray system |
| Quantity | 264 distributed worldwide (112 in the U.S.) |
| Distribution | Distributed throughout the United States. |
| Initiated | 2017-02-22 |
| Classified | 2017-03-22 |
| Terminated | 2017-10-24 |
| Recall number | Z-1534-2017 |
| 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-1534-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76713/
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