LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA device recall Z-0999-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- The Customer Advisory Notice (CAN) was sent to the affected customer on December 5, 2025. The CAN notifies the customer of the problem and provides steps the user should take to avoid the problem until the resolution software update is available. When switching within five seconds from a table related OGP to a bucky wall stand related OGP with top-alignment and then back to a table related OGP, it may happen, that the collimation is not adapted to the limitations of the detector. The active radiation field may thus extend beyond the limits of the detector, resulting in radiation outside of the area of the detector.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- U.S.: 1, OUS: 95
- Distribution
- U.S. and OUS
- Date initiated
- 2025-12-05
- Date posted
- 2026-01-08
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (K173639) | Siemens Medi Cal Solutions, Inc. | 2018-04-02 |