SIEMENS Luminos Agile Max — Class II medical device recall Z-1669-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-06-03, distributed nationwide. Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be
| Recall number | Z-1669-2015 |
|---|---|
| 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 | 2015-04-13 |
| Classified | 2015-05-23 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2017-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 133 total |
| Reason classes | software |
| Serial numbers | 61011, 61013, 61014, 61015, 61017, 61018, 61019, 61021, 61022, 61025, 61027, 61028, 61029, 61030, 61031, 61032, 61033, 61034, 61035, 61036, 61037, 61038, 61039, 61040, 61041 and 20 more |
Product
SIEMENS Luminos Agile Max; 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
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
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-1669-2015. 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.