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): 11574002, UDI-DI: 04056869993973, Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021 +12 more
- 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 R is an interventional fluoroscopic X-ray system used in medical settings for imaging during procedures. It helps healthcare professionals visualize and guide interventions in real time.
Why This Is Dangerous
The device may fail to flip ortho images as intended, which can lead to confusion and risk of misdiagnosis. This could result in serious patient safety issues if incorrect images are processed.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients could receive incorrect diagnoses or treatments based on erroneous imaging. This presents a serious risk for healthcare providers and impacts patient safety significantly.
Practical Guidance
How to identify if yours is affected
- Locate the Siemens Material Number (SMN): 11574002 on your device.
- Check against the list of serial numbers provided in the recall notice.
- Confirm if your unit was sold in the specified timeframe.
Where to find product info
Serial numbers can typically be found on the back or bottom of the device, often on a label affixed directly to the unit.
What timeline to expect
Expect a timeline of 4-8 weeks for refund processing or replacement after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with Siemens Medical Solutions USA.
- Consider reporting your experience to the FDA if you do not receive a timely response.
How to prevent similar issues
- Verify the recall status of medical devices prior to purchase.
- Check for FDA compliance and safety certifications when selecting medical equipment.
Documentation advice
Keep records of all communications, including emails and letters regarding the recall, and take photos of your device for reference.
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Product Details
The recalled product is the Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R, Siemens Material Number (SMN): 11574002, Software Version VB10D-SP02. The system was distributed widely, including states such as AK, IL, NY, VA, WI, and internationally in countries like Austria, Belgium, and Germany.
Key Facts
- Recall date: December 29, 2025
- Report date: February 4, 2026
- Total units recalled: 40
- Locations affected: US and several European countries
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Safety Guide
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