Z-1979-2014Class II

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

Name: Z-1979-2014 CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs...
Creator: Nihon Kohden America Inc
Published: 2014-06-03
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2014-06-03 / Terminated / root cause: software

FDA source

Nihon Kohden America Inc began a recall of CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients on 2014-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1979-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Posted: 2014-07-02
Terminated: 2015-04-28
Recalling firm: Nihon Kohden America Inc
Product: CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: Nihon Kohden sent an Urgent Medical Device Safety Notification and Field Correction letter dated June 3, 2014 to affected customers. Recall notification letter, dated June 3, 2014 was hand-delivered to site by Nihon personnel. The letter provided the following information: product description with codes and software version, reason for recall, field correction information and actions to be taken, MedWatch reporting information, and contact information for recall.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1979-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1979-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code MHX

K102376Class IINihon Kohden Cns-6200 Series Central Nurse Station, Model Cns-6201Nihon Kohden Corp. / cleared 2010-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)