Reported Feb 4, 2026 · Ongoing
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Interventional
- Fluoroscopic X-Ray SystemLUMINOS Q.namix R
- Siemens Material Number (SMN)
11574002With Software Version VB10D-SP02
- Lot codes and dates
- Siemens Material Number (SMN)11574002
- UDI-DI04056869993973
- Serial Numbers
150050150035150033150034150048150021150020150053150023150044150049150037150054150011150059150024150038150051150029150045150032150056150043150055150041150026150025150022150031150039150046150042150028150047150030150052150027150057150040150058150063
- Amount recalled
- 41 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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