Device recall
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
- Recall number
- Z-0089-2027
- Event id
- 99549
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Nihon Kohden America LLC
- Report date
- Oct 14, 2026
- Posted
- Oct 6, 2026
- Initiated
- Sep 8, 2026
- Center classification date
- Oct 6, 2026
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- 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.
- Root cause
- Software design
- Quantity
- 808
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K102376
- Location
- Irvine, CA, United States