Siemens Luminos Agile Max system The Luminos Agile is intended to be… — Class II medical device recall Z-0005-2015
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-0005-2015 |
|---|---|
| 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 | 5 |
| Reason classes | labeling, device malfunction |
| Serial numbers | 61011, 61013, 61014, 61015, 61017 |
Product
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
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
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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.