LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max… recallZ-0999-2026 · Siemens Medical Solutions USA, Inc · initiated Dec 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-0999-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2025
- Posted by the FDA
- Jan 8, 2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- U.S.: 1, OUS: 95
- Product code
- OWB
- FDA submissions
- K173639
- Distribution
- U.S. and OUS
Product description
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Code information (models, lots, serial numbers)
(01)04056869269931(21)10330
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LUMINOS Lotus Max 11574100Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system2 recalls7 reports
Other devices under the same FDA submission
1 device cleared under K173639 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Multitom Rax 10860700Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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