Events

Recall of Device Recall CNS6200 Series Central Nurse Station

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nihon Kohden America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68459
  • Event Risk Class
    Class 2
  • Event Number
    Z-1979-2014
  • Event Initiated Date
    2014-06-03
  • Event Date Posted
    2014-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127799
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 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.
  • 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.

Device

Device Recall CNS6200 Series Central Nurse Station
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 || For cardiac and vital signs monitoring for multiple patients.
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Manufacturer Address
    Nihon Kohden America Inc, 15353 Barranca Pkwy, Irvine CA 92618-2216
  • Manufacturer Parent Company (2017)
    Nihon Kohden Corp.
  • Source
    USFDA