Nihon Kohden America LLC recalls Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station

Recalling company

Nihon Kohden America LLC

Product

Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor. Component: No

Reason

Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 8, 2026

Reported

Oct 14, 2026

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.

Status

Ongoing

Quantity

808

Lot / codes

Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40

Company location

Irvine, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0089-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0089-2027 in the FDA Enforcement Report. Also see FDA recall press releases.