Drug recall
AXIOM Luminos Agile
FDA recall event 91383 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 91383 |
|---|---|
| Recall numbers | Z-1000-2023, Z-1001-2023, Z-1002-2023 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | AXIOM Luminos Agile, AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF, Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is potential for the footrest to detach from the patient table during use., 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… |
| Initiation date | Dec 9, 2022 |
| Report date | Jan 25, 2023 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: