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Steris Corporation: Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

Medical DevicesSource: FDA (device) · Date: 2026-02-18

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Steris Corporation
Product
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Recall initiated
2025-05-23
Code info
UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Product quantity
10 units
Voluntary mandated
Voluntary: Firm initiated
City
Mentor
State
OH
Country
United States
Event id
98266
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