Luminos Agile Max with software VE10 & VF11- A diagnostic imaging… — Class II medical device recall Z-1165-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-03-01, distributed nationwide. Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or
| Recall number | Z-1165-2023 |
|---|---|
| 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 | 2022-12-21 |
| Classified | 2023-02-23 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Serial numbers | 61014, 61036, 61067, 61078, 61142, 61148, 61171, 61186, 61189, 61216, 61224, 61624, 61629, 61631, 61641, 61652, 61659, 61664, 61718, 61775, 61776, 61818, 61857, 63243, 63268 and 3 more |
| Model numbers | 10762472 |
Product
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Reason for recall
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
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-1165-2023. 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.