—#217937

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173639
Affected lot / code info: (01)04056869269931(21)10330

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

The Customer Advisory Notice (CAN) was sent to the affected customer on December 5, 2025. The CAN notifies the customer of the problem and provides steps the user should take to avoid the problem until the resolution software update is available. When switching within five seconds from a table related OGP to a bucky wall stand related OGP with top-alignment and then back to a table related OGP, it may happen, that the collimation is not adapted to the limitations of the detector. The active radiation field may thus extend beyond the limits of the detector, resulting in radiation outside of the area of the detector.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: U.S. and OUS

Timeline

Recall initiated: 2025-12-05
Posted by FDA: 2026-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.