Class II — Nihon Kohden America Inc
| Recalling firm | NIHON KOHDEN CORP. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. |
| Product | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. |
| Quantity | 430 |
| Distribution | Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa. |
| Initiated | 2014-06-03 |
| Classified | 2014-07-02 |
| Terminated | 2015-04-28 |
| Recall number | Z-1979-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nihon Kohden America Inc (Z-1979-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68459/
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