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Open, Classified

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

FDA Recall Z-0089-2027 · Posted 2026-10-06

Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2026-09-08
Product Quantity808

Reason for Recall

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.

Firm Action

On 09/08/2026, an "URGENT: MEDICAL DEVICE CORRECTION" Letter was sent via USPS certified mail to customers informing that, Nihon Kohden Corporation announced the discovery of a vulnerability within a limited number of CNS-6201 models to Denial of Service (DoS) attacks. The identified vulnerability is classified as a NULL pointer dereference* (CWE-476). This type of software error may cause the system to crash when processing malformed or unexpected network input. Nihon Kohden has not received any complaints related to this vulnerability. If a CNS-6201 is affected by a DoS event, the device may stop its monitoring function due to a system crash, resulting in temporary loss of central monitoring functionality. Customers are instructed to: 1. Identify any affected CNS-6201 units in their inventory. 2. Complete the attached Medical Device Notification Return Response Form and email the completed Medical Device Notification Return Response Form back to NKA Technical Services at [email protected]. Issue Resolution a. Nihon Kohden Corporation advises that the customer upgrade to a successor product (e.g. CNS-2101). b. For customers who continue to operate CNS-6201 systems, Nihon Kohden reiterates the importance of implementing established cybersecurity controls that are part of the intended deployment architecture and long-standing cybersecurity guidance for these systems. These controls are not newly introduced mitigations but rather represent expected deployment requirements designed to support the secure operation of the system throughout its lifecycle. For questions - call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email [email protected].

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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