Lower riskMedical device recall · FDA · Published December 5, 2025
Siemens LUMINOS Lotus Max and dRF Max: Incorrect Collimation Risk
Siemens recalls two ultrasound systems due to potential incorrect collimation when switching between organ programs. Affected models include LUMINOS Lotus Max (11574100) and Luminos dRF Max (10762471).
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.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens LUMINOS Lotus Max and dRF Max: Incorrect Collimation Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50520-siemens-luminos-lotus-max-and-drf-max-incorrect-collimation-risk. Based on FDA recall #Z-0999-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2026%22&limit=1).
The FDA announced on Dec. 5, 2025, that Siemens Medical Solutions USA, Inc. is recalling LUMINOS Lotus Max and Luminos dRF Max systems due to a potential issue where collimation may be incorrect when switching quickly between organ programs. The agency classified the recall as Class II.
How to tell if you have it
LUMINOS Lotus Max, Model 11574100
Luminos dRF Max, Model 10762471
UPC 04056869269931
The hazard
The recall involves LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11, specifically those equipped with a bucky wall stand for mobile detectors and without a ceiling stand. When switching quickly between organ programs (OGPs), the collimation may be incorrect.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS icono floor recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Olympus Disposable Triple Lumen Sphincterotome Recall (Jan. 7, 2026) and the Canon Vantage Galan 3T Medical Device Recall (Oct. 16, 2025).
How to tell if you have this one
Check for the model numbers 11574100 (LUMINOS Lotus Max) or 10762471 (Luminos dRF Max) with software version VF11. These systems were sold with specific configurations including bucky wall stands for mobile detectors but without ceiling stands.
Brand
Siemens
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your device; affected units have version VF11.
How this recall unfolded
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0999-2026 (December 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0999-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.