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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- Medical Imaging Systems
- Model numbers
- 11574100, 10762471
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 5, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model number of your medical imaging system to see if it is 11574100 or 10762471.
- Verify the software version; the recall applies to VF11.
- 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.
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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
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Safety Guide
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