Recall Z-0089-2027
- Recall number
- Z-0089-2027
- Event number
- 99549
- Firm
- Nihon Kohden America LLC
- Firm FEI
- 2080783
- Product code
- MHX
- Status
- Open, Classified
- Initiated
- 2026-09-08
- Posted
- 2026-10-06
- Root cause
- Software design
- 510(k) numbers
- K102376, K102040, K033711, K093268, K033600, K000854, K113653, K061185, K000517, K173768, K100040, K192514, K080495, K252250, K040395, K942700, K051400, K132077, K040955, K990068, K040357, K073462, K131414, K131829, K001722, K250349, K082045, K950264, K260579, K062095
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
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.