Siemens Medical Solutions USA, Inc — Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 29, 2025
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.
What's affected?
- Product
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- Lot code
- Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;
Additional details
Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 units.
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