AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
FDA Recall #Z-1000-2023 — Class II — December 9, 2022
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.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
654 units
Distribution
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)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated