FDA recall, , Moderate risk
Siemens LUMINOS Q.Namix R and Q.Namix T Interventional Fluoroscopic X-Ray Systems
Interventional fluoroscopic X-ray systems may not flip ortho images and could process a previous patient's image.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, began a recall on December 29, 2025, of its Interventional Fluoroscopic X-Ray Systems, including the LUMINOS Q.namix T and LUMINOS Q.namix R, with Software Version VB10D-SP02. The FDA added the recall to its Enforcement Report on January 27, 2026.
The recall was initiated because 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.
The systems were distributed in Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia, Wisconsin, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, and Switzerland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Interventional Fluoroscopic X-Ray System: Luminos Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- UDI-DI
- 11574003
- 04056869993980
Interventional Fluoroscopic X-Ray System: Luminos Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
- UDI-DI
- 11574002
- 04056869993973
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia, Wisconsin and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98244
- Recall numbers
- Z-1174-2026 to Z-1175-2026
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
