LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Recall Z-0999-2026 · Posted 2026-01-08
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Recalling FirmSiemens Medical Solutions USA, Inc
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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