Events

Recall of Device Recall Neuropack Evoked Potential and EMG Measuring System

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
    36394
  • Event Risk Class
    Class 2
  • Event Number
    Z-0218-2007
  • Event Initiated Date
    2006-08-23
  • Event Date Posted
    2006-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48578
  • 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
    Constant current stimulation unit - Product Code GWF
  • Reason
    When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. this may result in a superficial burn on the patient if the stimulation is done for a long time.
  • Action
    All customers will be called by phone, then faxed the Product Notification starting 09/01/2006 Customers were instructed to indicate the serial numbers on each of your MS-210BK stimulators and fax the MS-210BK PRODUCT RECALLREPLACEMENT letter back to Nihon Kohden at: 949-580-15550 or email to customerservice@nkusa.com. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.

Device

Device Recall Neuropack Evoked Potential and EMG Measuring System
  • Model / Serial
    Any serial numbers up to 02160
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Manufacturer Address
    Nihon Kohden America Inc, 90 Icon, Foothill Ranch CA 92610-3000
  • Source
    USFDA