Recall Z-0999-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
| Date | Jan 8, 2026 (initiated Dec 5, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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 th |
| Quantity | U.S.: 1, OUS: 95 |
| Distribution | U.S. and OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |