FDA Device recall Z-0089-2027
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03,…
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03,… by Nihon Kohden America, citing due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple bed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0089-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-08 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Nihon Kohden America |
| Distribution | US |
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
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.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
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All Nihon Kohden America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2027%22
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