What should I do if I have used this X-ray system on patients?

Stop using the device immediately and inform your healthcare provider. Follow the recall instructions provided by Siemens Medical Solutions.

How can I identify if my unit is affected by this recall?

Check the Siemens Material Number (SMN): 11574002 and the listed serial numbers to determine if your unit is part of the recall.

Is it safe to continue using the device if it seems to be functioning normally?

No, it is not safe to continue using the device due to the risk of processing incorrect images.

Where can I find more information about this recall?

Visit the FDA's recall page or contact Siemens Medical Solutions USA for detailed information.

What are the risks associated with this X-ray system malfunction?

The malfunction may lead to displaying images from previous patients, which can result in misdiagnosis or incorrect treatment.

Can I get a refund or replacement for the recalled device?

Contact Siemens Medical Solutions USA for information on refunds or replacements related to the recall.

What is the classification of this recall?

This recall is classified as Class II, indicating a potential risk of temporary or medically reversible adverse health consequences.

How many units are affected by the recall?

A total of 40 units of the LUMINOS Q.namix R X-ray system are recalled.

What countries are affected by this recall?

The recall affects the United States and several European countries including Austria, Belgium, and Germany.

What is the urgency of this recall?

Healthcare providers should take immediate action to stop using the device due to the high risk associated with the imaging error.

HIGHDecember 29, 2025

Siemens Recalls Interventional Fluoroscopic X-Ray System Over Imaging Risk

Siemens Medical Solutions USA recalled 40 units of its LUMINOS Q.namix R X-ray system on December 29, 2025. The recall addresses a defect that may result in images being incorrectly processed, potentially showing images from previous patients. Healthcare providers should stop using the device immediately and follow recall instructions.

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

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

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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.

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

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

CategoryHealth & Personal Care › Medical Devices

Product TypeInterventional Fluoroscopic X-Ray System

Product Details

Oct 24, 2025

Siemens Medical Solutions USA

There were