FDA Device recall Z-1000-2023
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
- FDA Device
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF 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-1000-2023 |
| 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 TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Reason
There is potential for the footrest to detach from the patient table during use.
Identifiers
| code_info | All serial numbers 1) AXIOM Luminos TF, Material #10093902 (no UDI) 2) AXIOM Iconos R100, Material #05895151 (no UDI)…All serial numbers 1) AXIOM Luminos TF, Material #10093902 (no UDI) 2) AXIOM Iconos R100, Material #05895151 (no UDI) 3) AXIOM Iconos R200 C69, Material #10093961 (no UDI) 4) AXIOM Iconos R200 C20, Material #10093962 (no UDI) 5) AXIOM Luminos dRF, Material #10094200 (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-1000-2023%22
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