Recall Z-0999-2026— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0999-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-05

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-12-05. It names one FDA 510(k) clearance: K173639. Product: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-12-05
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.·cleared 2018-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.