AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom… — Class II medical device recall Z-2649-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-09-24, distributed nationwide. It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos
| Recall number | Z-2649-2014 |
|---|---|
| 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 | 2014-08-12 |
| Classified | 2014-09-16 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 33 |
| Reason classes | device malfunction |
| Model numbers | 10094200 |
Product
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Reason for recall
It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d
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-2649-2014. 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.