CNS-6200 Series Central Nurse Station and accessories — Class II medical device recall Z-1979-2014
Terminated recall by Nihon Kohden America Inc, reported 2014-07-09, distributed in OK. Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly an
| Recall number | Z-1979-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2014-06-03 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-04-28 |
| Distributed | OK |
| Countries outside the US | BO, CL, DE, JP, KR, TW, ZA |
| Quantity | 430 |
| Reason classes | software |
| Serial numbers | 00361, 00429, 00430, 00432, 00436, 00443, 00447, 00478, 00485, 00486, 00488, 00489, 00490, 00491, 00546, 00564, 00573, 00574, 00575, 00576, 00592, 00626, 00638, 00643, 00651 and 6 more |
| Model numbers | CNS-6201 |
Product
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.