Class II

Medical Device Recall: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Siemens Medical Solutions USA, Inc · December 5, 2025

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.

Distribution

U.S. and OUS

Quantity Affected

U.S.: 1, OUS: 95

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0999-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.