Axiom Artis fluoroscopic x-ray system — Class II medical device recall Z-1468-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-03-22, distributed nationwide. A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior.
| Recall number | Z-1468-2017 |
|---|---|
| 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 | 2017-02-27 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2019-01-14 |
| Distributed | Nationwide (US) |
| Serial numbers | 10000, 10003, 10006, 10007, 10008, 10009, 10010, 10012, 10014, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10024, 10025, 10027, 10029, 10030, 10031, 10036, 10038, 10039 and 475 more |
| Model numbers | 4787813 |
Product
Axiom Artis fluoroscopic x-ray system
Reason for recall
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
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-1468-2017. 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.