FDA Device recall Z-1001-2023
AXIOM Luminos Agile
- FDA Device
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of AXIOM Luminos Agile by Siemens Medical Solutions Usa, citing there is potential for the footrest to detach from the patient table during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-09 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
AXIOM Luminos Agile
Reason
There is potential for the footrest to detach from the patient table during use.
Identifiers
| code_info | All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.