Luminos dRF Max — Class II medical device recall Z-1480-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-05-31, distributed nationwide. Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact
| Recall number | Z-1480-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-11-23 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Model numbers | 10762471 |
Product
Luminos dRF Max (VE10, VF10, VF11)
Reason for recall
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
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-1480-2023. 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.