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Recall Observatory FDA recall evidence

Device product

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

Z-0999-2026

December 05, 2025

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 98230
Status
Ongoing
Classification
Class II
Quantity
U.S.: 1, OUS: 95
Official record key
device-enforcement:Z-0999-2026

Official wording

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.

Code information: (01)04056869269931(21)10330

Distribution pattern: U.S. and OUS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.