RecallDepth

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

Company
Siemens Medical Solutions Usa, Inc
Recall Initiated
December 5, 2025
Posted
January 8, 2026
Recall Number
Z-0999-2026
Quantity
U.S.: 1, OUS: 95
Firm Location
Malvern, PA

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

Lot / Code Info

(01)04056869269931(21)10330

Root Cause

Radiation Control for Health and Safety Act

Action Taken

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.

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