[pending] Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 1157400
Pending LLM rewrite. Source: FDA_DEVICE Z-1175-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Siemens Material Number (SMN): 11574003
- UDI-DI: 04056869993980
- Serial Numbers: 170013
- 170022
- 170023
- 170021
- 170020
- 170025
- 170026
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27