Luminos dRF Max — Class II medical device recall Z-1337-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-02-26, distributed nationwide. A software bug may lead to one image to be assigned to two different patients, which could potentially affect
| Recall number | Z-1337-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-01-08 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 46 |
| Reason classes | software |
| Serial numbers | 5037, 5043, 5049, 5069, 5072, 5085, 5086, 5120, 5151, 5163, 5188, 5190, 5209, 5234, 5278, 5299, 5352, 5355, 5364, 5372, 5611, 5634, 5682, 5690, 5719 and 21 more |
| Model numbers | 10762471 |
Product
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
Reason for recall
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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-1337-2020. 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.