Events

Recall of NicoletOne Software v5.94

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Neurology 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
    71991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0117-2016
  • Event Initiated Date
    2015-09-11
  • Event Date Posted
    2015-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139574
  • 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
    Full-montage Standard Electroencephalograph - Product Code GWQ
  • Reason
    When using the nicoletone v5.94 software, after exiting the impedance check function and returning to the eeg screen, the impedance check signal remains active in waveform, obscuring the eeg signals.
  • Action
    Natus Neurology sent an Ugent Medical Device Corrrection Notification letter dated September 9, 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were informed consignees that a Field Service Technician will contact them to install the new software. Once the software is installed they will ask the Recipient or Field service Technician to complete and return the Verification Form. For questions regarding this recall call 608-829-8600.

Device

NicoletOne Software v5.94
  • Model / Serial
    Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
  • Product Description
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. || The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data
  • Manufacturer
    Natus Neurology Inc

Manufacturer

Natus Neurology Inc
  • Manufacturer Address
    Natus Neurology Inc, 3150 Pleasant View Rd, Middleton WI 53562-4800
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA