FDA WARNING_LETTER - Nihon Kohden Digital Health Solutions, Inc. - February 24, 2026

On June 12, 2026, the FDA issued a warning letter to Nihon Kohden Digital Health Solutions, LLC, following an inspection of their Irvine, California facility in February 2026. The investigation focused on the company’s Next Generation NetKonnect (NGNK) software, a physiological monitoring device. The FDA determined that the device is currently adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to unauthorized modifications. Specifically, the FDA identified two major violations. First, the company implemented a software change allowing users to silence alarms without seeking a new 510(k) clearance. The FDA noted that this modification affects a critical control mechanism and could result in missed alarms for life-threatening conditions. Second, the company marketed the software as having "device-agnostic compatibility," supporting third-party hardware and software beyond the scope of its original clearance. This unauthorized expansion of intended use introduces risks regarding interoperability and the accuracy of vital sign measurements. Nihon Kohden is required to provide a written response within 15 business days outlining the steps taken to correct these violations and prevent their recurrence. Failure to address these issues promptly may result in further regulatory action, including product seizures, injunctions, or financial penalties.