Clinic software
Warning letter 727803, Nihon Kohden software
FDA told Nihon Kohden Digital Health Solutions that a hospital monitoring program, Next Generation NetKonnect, was changed after clearance — a silent-alarms switch, and a claim that it would take inputs from other manufacturers’ devices — without a new 510(k).
The inspection of the Irvine, California firm ran February 23–24, 2026. The software is a class II arrhythmia detector and alarm under 21 CFR 870.1025, last cleared as K220989 on July 29, 2022. On October 22, 2022, the firm added a Silence Alarms function and filed it as a letter-to-file. At the “control mechanism” question on its own form, it checked no. FDA disagrees: silencing alarms changes how the user controls the device and “may result in missed alarms for life-threatening conditions.” That, the letter says, needs a new 510(k).
The labeling also claims “device-agnostic compatibility.” Management told investigators that meant any off-the-shelf computer and inputs from non-Nihon Kohden devices. The 2022 clearance, FDA writes, covered inputs from Nihon Kohden devices only. Unvalidated interoperability, the letter says, can produce wrong vital signs or a loss of monitoring.
This is a software-change letter, not a billing case. The product lives in the clinic: a monitor with an alarm the user can now turn off, talking to machines it was not cleared to hear.
fda.gov — Nihon Kohden Digital Health Solutions, LLC — 727803 — 06/12/2026
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.