Siemens RAD Fluoro Uro System — Class II medical device recall Z-1845-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-07-02, distributed nationwide. When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result
| Recall number | Z-1845-2014 |
|---|---|
| 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 | 2013-08-28 |
| Classified | 2014-06-20 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 76 |
| Reason classes | device malfunction, software |
| Model numbers | 10094910, 10281013, 10281163 |
Product
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Reason for recall
When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
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-1845-2014. 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.