{"recall":{"id":"fda-device-99549","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Nihon Kohden America LLC recalls Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station","firm":"Nihon Kohden America LLC","date":"2026-09-08","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40","quantity":"808","number":"Z-0089-2027","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"808","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99549","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"92036a46b76048b5","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99549","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99549","recalling_firm":"Nihon Kohden America LLC","address_1":"15353 Barranca Pkwy","address_2":"N/A","postal_code":"92618-2216","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-0089-2027","product_description":"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_quantity":"808","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.","recall_initiation_date":"20260908","center_classification_date":"20261006","report_date":"20261014","code_info":"Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40"}]}}