Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIOngoing
Summary: Siemens Medical Solutions USA, Inc is recalling Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02. Reason: 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 is being recalled
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia, Wisconsin)
How to tell if yours is affected
Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1175-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 29, 2025 |
| Reported | February 4, 2026 |
| Company | Siemens Medical Solutions USA, Inc |
| Company location | Malvern, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
More recalls from Siemens Medical Solutions USA, Inc · all medical device recalls · recalls from December 2025