—#218080

Product

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

FDA product code: KQM — Camera, Surgical And Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

All affected Customers have been contacted by a STERIS Service Technician arranging an onsite inspection of their unit(s) to locate and replace the affected MNA(s). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Diksha Chechi, Quality Manager at 510-439-4500.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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

Timeline

Recall initiated: 2025-05-23
Posted by FDA: 2026-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.