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Open, Classified

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

FDA Recall Z-0999-2026 · Posted 2026-01-08

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-12-05
Product QuantityU.S.: 1, OUS: 95

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.

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and OUS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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