Official recall record
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04056869269931
- Brand on record
- Siemens Medical Solutions USA, Inc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-07-02 · US FDA — Medical Devices
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode
Other recalls from this brand
- 2026-03-12 · US FDA — Medical Devices
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-10 · US FDA — Medical Devices
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. - 2026-03-09 · US FDA — Medical Devices
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
All 23 official recall notices naming Siemens Medical Solutions USA, Inc on this site →