Steris Corporation Recalls Barco MNA with HexaVue IP Integration System Due to Configuration Error

What Happened

Steris Corporation has initiated a voluntary Class II recall of the Barco MNA with the HexaVue IP Integration System. The recall was triggered after the supplier identified that an incorrect configuration file was used during the manufacturing process for a limited batch of MNA-6x0 (adapter) components. This action is a sub-recall of event RES 96885.

Which Products Are Affected

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

A total of 10 units are affected, identified by the following serial numbers:

• 2531542441
• 2531542470
• 2531543549
• 2531543611
• 2531572419
• 2531572433
• 2531572440
• 2531588558
• 2531593768
• 2531595829

The UDI-DI for these products is 00724995220570. The affected units were distributed in Florida, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.

What You Should Do

Steris Corporation notified affected customers via a formal letter. Facilities in possession of the specific serial numbers listed above should follow the instructions provided in the firm’s notification regarding the resolution of the configuration error. For further inquiries, customers should contact Steris Corporation at their Mentor, Ohio headquarters.

Why This Matters

This recall addresses a manufacturing defect in medical device components that could lead to improper system configuration. Ensuring the correct software and configuration files are present is critical for the reliable operation of IP integration systems in medical environments.

Source

FDA Recall Notice Z-1361-2026