FDA-Device2026-02-04Class IIPROCESSING DEFECT
Siemens LUMINOS Q.namix T X-ray system recalled for image processing error
OTHERNationwide distribution
Contact Siemens about your LUMINOS Q.namix T system
Certain Siemens LUMIOS Q.namix T interventional X-ray systems with software version VB10D-SP02 may fail to flip orthopedic images as intended when using automatic horizontal flip settings. In some cases, this could result in processing an image from a previous patient instead of the current one.
- Check if your facility uses a LUMINOS Q.namix T system with the affected serial numbers (170013, 170020, 170021, 170022, 170023, 170025, or 170026)
- Contact Siemens Medical Solutions USA immediately if you have an affected unit
- Do not perform orthopedic imaging with automatic horizontal flip preset until instructed otherwise by Siemens
- Verify patient identity carefully when reviewing acquired images
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
7 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2026More Siemens Medical Solutions USA, Inc recalls
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