Luminos Agile Max — Class II medical device recall Z-1479-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-05-31, distributed nationwide. Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact
| Recall number | Z-1479-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-11-23 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Model numbers | 10762472 |
Product
Luminos Agile Max (VE10, VF10, VF11)
Reason for recall
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
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-1479-2023. 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.