Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Recall date

December 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0999-2026

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

U.S. and OUS

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471