LUMINOS Lotus Max recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIOngoing
Summary: Siemens Medical Solutions USA, Inc is recalling LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471. 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.
What is being recalled
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. and OUS
How to tell if yours is affected
(01)04056869269931(21)10330
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0999-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 5, 2025 |
| Reported | January 14, 2026 |
| Company | Siemens Medical Solutions USA, Inc |
| Company location | Malvern, PA, United States |
| Initiated by | FDA Mandated |
| Quantity | U.S.: 1, OUS: 95 |
More recalls from Siemens Medical Solutions USA, Inc · all medical device recalls · recalls from December 2025