FDAHealthDecember 5, 2025
Siemens Medical Solutions USA, Inc — LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- December 5, 2025
U.S. and OUS
What's affected?
- Product
- LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Lot code
- (01)04056869269931(21)10330
Additional details
(01)04056869269931(21)10330
What should I do?
Recommended action
Class II recall. FDA Mandated Quantity affected: U.S.: 1, OUS: 95.
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