Class II recall Z-0089-2027: Nihon Kohden America LLC
Class II recall Z-0089-2027: Nihon Kohden America LLC (California): Nihon Kohden America LLC. Dated 22 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0089-2027: Nihon Kohden America LLC and 76 California peers
- California FDAPulse records like this one: 76
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.
What is the FDAPulse record for Class II recall Z-0089-2027: Nihon Kohden America LLC in California?
Class II device recall Z-0089-2027 by Nihon Kohden America LLC: Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cau
How does Class II recall Z-0089-2027: Nihon Kohden America LLC compare to other California FDAPulse records?
It is 22 days old, still within a typical 45-day follow-up window.
Class II recall Z-0089-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0089-2027 | CA | 2026-10-14 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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