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FDA Device recall Z-1979-2014

CNS-6200 Series Central Nurse Station and accessories

On 2014-07-09 the FDA classified a Class II recall of CNS-6200 Series Central Nurse Station and accessories by Nihon Kohden America, citing 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 mi….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1979-2014
ClassificationClass II
Statusterminated
Initiated2014-06-03
Published2014-07-09
Last updated2026-09-13 11:53 UTC
CompanyNihon Kohden America
DistributionOK

Product

CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.

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.

Identifiers

code_info
Model Number: CNS-6201 Software Version 02-26 only. Serial Numbers: 00485, 00488, 00489, 00490, 00491, 0…Model Number: CNS-6201 Software Version 02-26 only. Serial Numbers: 00485, 00488, 00489, 00490, 00491, 00361, 00429, 00430, 00432, 00436, 00443, 00447, 00478, 00486, 00546, 00564, 00573, 00574, 00575, 00576, 00592, 00626, 00638, 00643, 00651, 00674, 00675, 00677, 00678, 00679, 00687.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1979-2014%22

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