Z-0089-2027

Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software...

Name: Z-0089-2027 Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software...
Creator: Nihon Kohden America LLC
Published: 2026-09-08
License: https://open.fda.gov/license/

Nihon Kohden America LLC / initiated 2026-09-08 / Open, Classified

FDA source

Recall record

Recall number: Z-0089-2027
Status: Open, Classified
Initiated: 2026-09-08
Posted: 2026-10-06
Recalling firm: 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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA root cause: Software design
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].
Quantity in commerce: 808
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.
Product codes and lots: Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40

Product code MHX

K102376Class IINihon Kohden Cns-6200 Series Central Nurse Station, Model Cns-6201Nihon Kohden Corp. / cleared 2010-12-07

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)