Quick Facts at a Glance
- Recall Date
- December 29, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- 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
- Interventional Fluoroscopic X-Ray System
- Model numbers
- Siemens Material Number (SMN): 11574003, UDI-DI: 04056869993980, Serial Numbers: 170013, 170022, 170023, 170021, 170020
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 29, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
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. Notification method: Letter
About This Product
The LUMINOS Q.namix T is an advanced fluoroscopic X-ray system used in various medical settings for imaging and diagnostics. Healthcare providers rely on accurate imaging to assess patient conditions and make treatment decisions.
Why This Is Dangerous
The defect causes images that should be automatically flipped to remain unchanged, leading to possible erroneous imaging of previous patients. This can result in misdiagnosis or inappropriate treatment based on incorrect patient data.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause significant disruptions in medical facilities that rely on this imaging technology, potentially impacting patient care and diagnosis.
Practical Guidance
How to identify if yours is affected
- Locate the Siemens Material Number (SMN) on the device.
- Check the serial numbers against those listed in the recall notice.
- Contact Siemens Medical Solutions if you are unsure about your device's status.
Where to find product info
Serial numbers and Siemens Material Numbers can be found on the device's identification label, usually located on the back or side of the machine.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Follow up with Siemens Medical Solutions via phone or email.
- Document your communications and attempts to resolve the issue.
How to prevent similar issues
- When purchasing medical devices, ensure they comply with regulatory standards.
- Regularly check for recall information from manufacturers and the FDA.
- Consider devices with robust customer support and warranty options.
Documentation advice
Keep records of all correspondence with the manufacturer, including emails and phone call notes, as well as copies of any receipts or warranty documents.
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Product Details
The recalled product is the LUMINOS Q.namix T Interventional Fluoroscopic X-Ray System, Siemens Material Number (SMN): 11574003, with Software Version VB10D-SP02. The recall involves five units distributed worldwide, including states such as AK, IL, NY, VA, and WI.
Key Facts
- Five units recalled
- Software processing error
- Potential for incorrect patient images
- Immediate action required
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Safety Guide
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