Luminos Agile Max — Class II medical device recall Z-1002-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-01-25. There is potential for the footrest to detach from the patient table during use. Device intended to visualize
| Recall number | Z-1002-2023 |
|---|---|
| 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 | 2022-12-09 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Quantity | 886 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04056869009155, 04056869009162 |
Product
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Reason for recall
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray 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. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
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-1002-2023. 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.