FDA recall, , Moderate risk
Siemens LUMINOS Lotus Max and Luminos dRF Max
Luminos Lotus Max and Luminos dRF Max systems may have incorrect collimation when switching quickly between organ programs.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, recalled the LUMINOS Lotus Max, Model 11574100, and Luminos dRF Max, Model 10762471, because a potential issue with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand may cause incorrect collimation when switching quickly between organ programs. The recall began December 5, 2025, and was added to the FDA's Enforcement Report on January 8, 2026. The distribution included the U.S. and OUS.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
LUMINOS Lotus Max
- Model number
- 11574100
- UDI-DI
- 04056869269931
Luminos dRF Max
- Model number
- 10762471
Recall details
- Company began the recall
- Sold in
U.S. and OUS
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98230
- Recall number
- Z-0999-2026
- Quantity recalled
- U.S.: 1, OUS: 95
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
