Siemens Luminos dRF — Class II medical device recall Z-2292-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-09-17, distributed nationwide. It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with
| Recall number | Z-2292-2014 |
|---|---|
| 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 | 2014-07-07 |
| Classified | 2014-09-10 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 192 |
| Reason classes | device malfunction, software |
| Model numbers | 10094200, 10094910, 10281013, 10281163 |
Product
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Reason for recall
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
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-2292-2014. 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.