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 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.
The recall stems from the use of an incorrect configuration file during manufacturing. This defect poses significant safety risks as it may lead to malfunction of the medical device, potentially affecting patient care.
There are no reported incidents or injuries linked to this recall. The lack of incidents does not negate the potential hazards associated with the defective configuration.
Stop using the product immediately. Follow the recall instructions provided by Steris Corporation and contact your healthcare provider for further guidance.
Consumers can find more information and instructions at the official FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1361-2026.
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