Lower risk Medical device recall · FDA · Published December 29, 2025

Siemens LUMINOS Q.namix R X-Ray System Recall: Image Misalignment Risk

Siemens recalls specific LUMINOS Q.namix R X-ray systems with software version VB10D-SP02 due to potential display of previous patient images during single image acquisition. Affected units have unique serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1174-2026Medical device Siemens ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling certain LUMINOS Q.namix R X-ray systems that may display images of previous patients during single image acquisition. This could lead to unintended patient image overlap in medical procedures, though the risk is not immediately dangerous. Read more at govinfonow.com/recall/50333-siemens-luminos-q-namix-r-x-ray-system-recall-image.

Source Summary by GovInfoNow · govinfonow.com/recall/50333-siemens-luminos-q-namix-r-x-ray-system-recall-image · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1174-2026

Cite this page

“Siemens LUMINOS Q.namix R X-Ray System Recall: Image Misalignment Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50333-siemens-luminos-q-namix-r-x-ray-system-recall-image. Based on FDA recall #Z-1174-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1174-2026%22&limit=1).

The FDA announced on Dec. 29, 2025, that Siemens Medical Solutions USA, Inc. is recalling its Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R due to software errors that may cause unflipped ortho images or processing of previous patient data. This voluntary Class II recall affects 41 units distributed worldwide.

How to tell if you have it

Brand: Siemens
Product: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R
Siemens Material Number (SMN): 11574002
Software Version: VB10D-SP02
UDI-DI: 04056869993973
Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063

The hazard

The recall addresses a hazard where ortho images acquired with preset automatic horizontal flip are not flipped. Additionally, when acquiring single images, there is the possibility that an image of a previous patient may be processed.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar product recalls include GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall and GE Healthcare Enterprise Archive V8 Software Recall (both July 31, 2026), which cited patient data mismatch risks.

How to tell if you have this one

Check if your X-ray system has the Siemens Material Number (SMN) 11574002 and software version VB10D-SP02. Affected units have specific serial numbers listed in the recall notice, including 150050, 150035, and other numbers provided in the official notice.

Brand
Siemens
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.

Recall number	Product, codes & lots	Quantity
Z-1174-2026	Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02; Siemens Material Number (SMN): 11574002; UDI-DI: 04056869993973; Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063;	41 units
Z-1175-2026	Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02; Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;	7 units

Based on the official FDA remedy

What to do — step by step

Check System Details
Verify your X-ray system's serial number against the list of affected units provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia, Wisconsin.

Recall timeline

FDA published this recall 37 days after the firm started it.

Dec 29, 2025Firm started the recall
Jan 27, 2026FDA classified it Class II
Feb 4, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous for patients?

The recall addresses a potential image overlap issue but does not indicate immediate danger to patients. The risk is low and relates to image misalignment during procedures.

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Link to this recall

<a href="https://govinfonow.com/recall/50333-siemens-luminos-q-namix-r-x-ray-system-recall-image">Siemens LUMINOS Q.namix R X-Ray System Recall: Image Misalignment Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1174-2026 (December 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1174-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.