Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
FDA Recall #Z-1361-2026 — Class II — May 23, 2025
Product Description
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Reason for Recall
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Recalling Firm
Steris Corporation — Mentor, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Code Information
UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated