AXIOM Luminos Agile
FDA Recall #Z-1001-2023 — Class II — December 9, 2022
Product Description
AXIOM Luminos Agile
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
271 units
Distribution
Worldwide distribution
Code Information
All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated