Barco N.V. is recalling two units of the Barco MDSC-8527 NXF surgical display, part number K9352421. A manufacturing defect involving the internal I2C cables has caused the built-in MNA decoder functionality to be blocked. This defect prevents the medical device from properly decoding and displaying video signals as intended. These units were distributed to medical facilities in New Jersey in late 2023.
The failure of the internal decoder means the surgical display cannot process specific video signals, which could lead to a loss of visual information or video delays during medical procedures. While no injuries have been reported, a malfunctioning surgical monitor can disrupt clinical workflows and delay critical surgical steps.
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Sources: FDA iRES · Raw API Response
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