Events

Recall of Device Recall Neuro Works

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Neurology DBA Excel Tech., Ltd. (XLTEK).

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
    72763
  • Event Risk Class
    Class 2
  • Event Number
    Z-0581-2016
  • Event Initiated Date
    2015-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142174
  • 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
    During an internal testing, natus medical incorporated, identified that in neuro works 8.1 with quantum hardware, the incoming signal is displayed with reversed polarity.
  • Action
    The firm, Natus Neurology, sent an "Urgent Medical Device Correction Notification" letter on 11/11/2015. The letter described the the problem, the product involved in the recall and actions to be taken. Natus will provide further information once an updated software is released. The consignees were instructed to complete and return the confirmation form by mail to Senior Manager Quality and Regulatory Affairs, Excel-Tech, Ltd (XLTEK) Division, Natus Medical Incorporated, 2568 Bristol Circle, Oakville, ON L6H 5S1 or by email to :ots@natus.com. If you have any questions, contact Senior Manager Quality and Regulatory Affairs at 905-287-5055 or email: sanjay.mehta@natus.com.

Device

Device Recall Neuro Works
  • Model / Serial
    Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .
  • Product Description
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. || The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
  • Manufacturer
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Manufacturer

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
  • Manufacturer Address
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK), 2568 Bristol Cir, Oakville Canada
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA