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U.S. Department of Health and Human Services

Class 2 Device Recall Nihon Kohden CNS6200 Series Central Nurse Station

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 Class 2 Device Recall Nihon Kohden CNS6200 Series Central Nurse Stationsee related information
Date Initiated by FirmSeptember 08, 2026
Date PostedOctober 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0089-2027
Recall Event ID 99549
510(K)NumberK102376 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductProduct 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
Code Information Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40
FEI Number 2080783
Recalling Firm/
Manufacturer		 Nihon Kohden America LLC
15353 Barranca Pkwy
Irvine CA 92618-2216
For Additional Information Contact
800-3250283
Manufacturer 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 Determined
Cause 2		Software design
ActionOn 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 vitalsignsTS@nihonkohden.com. 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 vitalsignsTS@nihonkohden.com.
Quantity in Commerce808
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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