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Recall Observatory FDA recall evidence

Device product

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

Z-1361-2026

May 23, 2025

Class II

Product summary

Firm
Steris Corporation
Event
Event 98266
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1361-2026

Official wording

Reason: 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.

Code information: UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

Distribution pattern: US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.