An assembly error was discovered on the cortical module (PN 190296-200). A cortical module insulator that is used to provide an electric barrier between circuit boards for TCS-9, ICS, and other internal parts was found to be installed incorrectly. The insulator provides clearance between safety critical components and incorrect installation does not meet the minimum creepage/air gap required to meet IEC 60601-1. Recall start date: April 23, 2024
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