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Siemens Medical Solutions USA, Inc: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Medical DevicesSource: FDA (device) · Date: 2026-01-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Medical Solutions USA, Inc
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. and OUS
Recall initiated
2025-12-05
Code info
(01)04056869269931(21)10330
Product quantity
U.S.: 1, OUS: 95
Voluntary mandated
FDA Mandated
City
Malvern
State
PA
Country
United States
Event id
98230
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