Reported Jan 14, 2026 · Ongoing
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
LUMINOS Lotus MaxModel 11574100 and Luminos dRF MaxModel 10762471
- Lot codes and dates
- (01)04056869269931(21)10330
- Amount recalled
- U.S.: 1, OUS: 95
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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