Interventional Fluoroscopic X-Ray System: LUMINOS Q — Class II medical device recall Z-1174-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-02-04, distributed nationwide. Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images,
| Recall number | Z-1174-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-12-29 |
| Classified | 2026-01-27 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, DK, ES, FR, GR, IE, IT, NL, NO, SE, ZA |
| Quantity | 41 units |
| UPC / GTIN / UDI-DI | 04056869993973 |
| Serial numbers | 150011, 150020, 150021, 150022, 150023, 150024, 150025, 150026, 150027, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044 and 16 more |
Product
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1174-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.