Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is… — Class II medical device recall Z-0003-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-10-08, distributed nationwide. Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Ma
| Recall number | Z-0003-2015 |
|---|---|
| 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 | 2014-09-02 |
| Classified | 2014-10-02 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | labeling, device malfunction |
| Serial numbers | 5037 |
Product
Siemens AXIOM Luminos dRF Max systems 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
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images
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-0003-2015. 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.