ARTIS Q — Class II medical device recall Z-1534-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-03-29, distributed nationwide. In Artis systems with A100G generators, a component can be affected by aging which could result in the potenti
| Recall number | Z-1534-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-02-22 |
| Classified | 2017-03-22 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 264 distributed |
| Serial numbers | 103001, 103008, 103013, 105007, 109007, 109009, 109010, 109011, 109015, 109016, 109020, 109021, 109027, 109028, 109029, 109031, 109032, 109033, 109034, 109036, 109038, 109039, 109040, 109041, 109043 and 87 more |
| Model numbers | 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 |
Product
ARTIS Q, Interventional Fluroscopic x-ray system
Reason for recall
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.
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-1534-2017. 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.