Home / Recalls / Siemens Medical Solutions USA, Inc / Z-1000-2023

Z-1000-2023 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1000-2023 was initiated by Siemens Medical Solutions USA, Inc on Dec 9, 2022 and is designated Class II. Reason for recall: There is potential for the footrest to detach from the patient table during use. The recall status is ongoing. Affected quantity: 654 units.

Recall Details

Product Type: Devices
Report Date: Jan 25, 2023
Initiation Date: Dec 9, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 654 units

Product Description

AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Reason for Recall

There is potential for the footrest to detach from the patient table during use.

Distribution Pattern

Worldwide distribution

Code Information

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)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1000-2023
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.