LUMINOS Lotus Max — Class II medical device recall Z-0999-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-01-14. A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 wit
| Recall number | Z-0999-2026 |
|---|---|
| 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 | 2025-12-05 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869269931 |
| Model numbers | 10762471, 11574100 |
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Reason for recall
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
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-0999-2026. 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.