Steris recalled 10 units of the Barco MNA with HexaVue IP Integration System on May 23, 2025. A manufacturing error used an incorrect configuration file in a limited batch of adapter components. The recall is classified as Class II and affects states including Florida and Texas.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Steris Corporation or your healthcare provider for instructions. Notification method: Letter
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The Barco MNA with HexaVue IP Integration System is used in healthcare settings for integrating various medical devices. Consumers purchase this product to enhance patient care and streamline medical operations.
The hazard arises from an incorrect configuration file used during the manufacturing of the adapter. This defect can lead to improper functioning of the medical device, affecting its reliability.
This recall is not part of a broader industry pattern.
Consumers must stop using the device immediately due to its high hazard classification. The recall affects a limited quantity of units, posing a significant risk to patient safety.
Serial numbers are typically found on the device label or packaging. Check documentation that came with the product.
Expect a refund processing timeline of 4 to 6 weeks after initiating your return.
Keep receipts, correspondence related to the recall, and any product identification numbers as records.
The recalled product is the Barco MNA with HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H. The affected serial numbers include 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829. It was distributed nationwide in Florida, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.
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