(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF,… — Class II medical device recall Z-0374-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-12-04, distributed nationwide. A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uro
| Recall number | Z-0374-2014 |
|---|---|
| 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 | 2013-09-03 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 357 |
| Reason classes | device malfunction, software |
| Model numbers | 10094200, 10094910, 10281013, 10281163, 10502200 |
Product
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Reason for recall
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
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-0374-2014. 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.