FDA-Device2026-01-14Class II
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc
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.
Sold states
U.S. and OUS
Affected count
U.S.: 1, OUS: 95
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2026Don't want to check this manually?
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