Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 1157400
Pending LLM rewrite. Source: FDA_DEVICE Z-1174-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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 R; Siemens Material Number (SMN): 11574002; 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 (20)
- Siemens Material Number (SMN): 11574002
- UDI-DI: 04056869993973
- Serial Numbers: 150050
- 150035
- 150033
- 150034
- 150048
- 150021
- 150020
- 150053
- 150023
- 150044
- 150049
- 150037
- 150054
- 150011
- 150059
- 150024
- 150038
- 150051
Distribution
Distributed nationwide across the United States.
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