Events

Recall of Device Recall Nicolet EEG Wireless Amplifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Neurology Incorporated.

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
    64479
  • Event Risk Class
    Class 2
  • Event Number
    Z-0946-2013
  • Event Initiated Date
    2013-02-27
  • Event Date Posted
    2013-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116224
  • 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
    Amplifier, physiological signal - Product Code GWL
  • Reason
    Natus neurology incorporated is recalling the nicolet eeg wireless amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. the overheating may result in discomfort ranging from too hot up to the potential for a burn.
  • Action
    Natus sent an "Urgent Medical Device Correction and Removal Notification' letter dated February 27, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter advised customers that a Natus Field Service technician will remove and replace the affected product at no charge to the users. The letter also advised if any of the affected products have been transferred to another location to please forward a copy of the letter and to notify Natus. For questions call 800-356-0007 ext. 5129.

Device

Device Recall Nicolet EEG Wireless Amplifier
  • Model / Serial
    C110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019 C110318006 C110318013 C110519022 C110519021 C110323024 C110323039 C110323037 C110323034 C110519003 C110323011 C110323007 C110815003 C110323040 C110815030 C110815015 C110517040 C110815026 C110519031 C110519030 C110513015    C110519035 C110318009 C110815020 C110519023 C110519023 C110815001 C110519010 C110519017 C110318018 61855 C110519002 C110323006 38249   C110815007 C110323036  C110519007 C110519012 C110519027 C110318008 C110318016 C110318026 C110318027 C110519008 C110519009 C110815023 C110815013 C110519034 C110519029 C110323050  C110118018 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015  C110201021 C110318001   C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C110318016 C110318002 C110815016 C110815012 RC110125M C110323018 C110815024 A4312 & A4314 C110318014 C110318011 C110318015 34902 C110815011 C110309001 C110519002 A42A0 C110318025 C110519036 C110519028 C110519024 C110519013 C110318005
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM
  • Product Description
    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. || Product Usage: || The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
  • Manufacturer
    Natus Neurology Incorporated

Manufacturer

Natus Neurology Incorporated
  • Manufacturer Address
    Natus Neurology Incorporated, 1850 Deming Way, Middleton WI 53562-3530
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA