# Class II recall Z-0089-2027: Nihon Kohden America LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0089-2027 |
| Recalling firm | Nihon Kohden America LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 ar |
| 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. |
| Quantity | 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. |
| Recall initiated | 2026-09-08 |
| Reported | 2026-10-14 |
| Firm location | Irvine, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.