HIGH

Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk

Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.

Quick Facts at a Glance

Recall Date
December 5, 2025
Hazard Level
HIGH
Brand
Siemens Medical Solutions USA
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions

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About This Product

The LUMINOS Lotus Max and Luminos dRF Max are advanced medical imaging systems designed for various diagnostic purposes. Healthcare providers purchase these systems to enhance imaging capabilities and improve patient care.

Why This Is Dangerous

The collimation error occurs when the device fails to accurately focus radiation beams during imaging, which can lead to incorrect diagnostics. This situation could potentially compromise patient safety and treatment decisions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare facilities using these systems, necessitating immediate action to prevent potential misdiagnoses and ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your medical imaging system to see if it is 11574100 or 10762471.
  2. Verify the software version; the recall applies to VF11.
  3. Confirm if the device is equipped with a bucky wall stand and does not have a ceiling stand.

Where to find product info

Model numbers and software versions can typically be found on the device's identification label or in the user manual.

What timeline to expect

Expect a response regarding refund or replacement instructions within 4-6 weeks.

If the manufacturer is unresponsive

  • Document all correspondence with Siemens Medical Solutions.
  • Follow up with your healthcare provider for assistance.
  • Consider contacting the FDA if there is no response.

How to prevent similar issues

  • Research safety certifications and compliance standards for medical imaging systems.
  • Consult with healthcare professionals about the latest technology and recalls before purchasing.
  • Regularly check for safety updates and recalls on medical devices.

Documentation advice

Keep all documentation related to the recall, including receipts, emails, and notes from communications with the manufacturer.

Product Details

The recalled products include LUMINOS Lotus Max (Model 11574100) and Luminos dRF Max (Model 10762471). The systems were distributed in the U.S. and internationally, with a total of 96 units recalled.

Key Facts

  • Siemens recalled LUMINOS Lotus Max and dRF Max systems
  • Potential collimation error when switching organ programs
  • 96 units affected, distributed in U.S. and internationally
  • Patients and providers must stop use immediately
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMedical Imaging Systems
Sold At
Multiple Retailers

Product Details

Model Numbers
11574100
10762471
Report Date
January 14, 2026
Recall Status
ACTIVE

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