AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used… — Class II medical device recall Z-1711-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-06-11, distributed in CA, CO, FL, GA, IL, IN, ME, MI…. It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a high
| Recall number | Z-1711-2014 |
|---|---|
| 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 | 2014-04-11 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-12-15 |
| Distributed | CA, CO, FL, GA, IL, IN, ME, MI, MN, MO, NJ, NY, OH, OK, OR, PA, TN, TX, VA |
| Quantity | 37 |
| Serial numbers | 3050, 3053, 3061, 3090, 3096, 3098, 3108, 3114, 3145, 3181, 4024, 4043, 4051, 4077, 4143, 4151, 4156, 4199, 4201, 4208, 4238, 4251, 4252, 4276, 4291 and 12 more |
| Model numbers | 10094200 |
Product
AXIOM Luminos dRFsystem 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 under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
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-1711-2014. 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.