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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Siemens LUMINOS Q.namix R X-ray system recalled for image display and patient data mix-up risk

Siemens
OTHERNationwide distribution

Contact Siemens about your LUMINOS Q.namix R X-ray system

Certain Siemens interventional X-ray systems with software version VB10D-SP02 have a software issue that can cause images to display incorrectly. When the automatic image-flip feature is used, images may not flip as expected, and in some cases, a previous patient's image could appear instead of the current patient's image.

  • If you operate or maintain a LUMINOS Q.namix R system (SMN 11574002), contact Siemens Medical Solutions USA immediately for guidance.
  • Do not rely on the automatic horizontal flip feature until Siemens provides a software update or fix.
  • Verify patient images manually before clinical use to ensure correct patient data is displayed.
Hazard

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.

Sold states
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.
Affected count
41 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2026

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