Recall archive / FDA device enforcement
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 — FDA record Z-0999-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- U.S.: 1, OUS: 95
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0999-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (01)04056869269931(21)10330 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. and OUS
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 14, 2026
- Recall initiation date
- Dec 5, 2025
- Center classification date
- Jan 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.