LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Recall #Z-0999-2026 — Class II — December 5, 2025
Product Description
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.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
U.S.: 1, OUS: 95
Distribution
U.S. and OUS
Code Information
(01)04056869269931(21)10330
Status
Ongoing
Voluntary / Mandated
FDA Mandated