Events

Recall of Device Recall NicoletOne monitoring system version 5.20 software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nicolet Biomedical Div of Viasys Healthcare.

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
    36241
  • Event Risk Class
    Class 3
  • Event Number
    Z-0380-2007
  • Event Initiated Date
    2006-08-25
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48241
  • 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
    patient monitoring system - Product Code GWQ
  • Reason
    A software anomaly exists in the 5.20.1038 nicoletone ltm, sleep, neeg, veeg and icu monitor systems using the m, and/or c series amplifiers. if this anomaly occurs, the system will display the data for channel one in all channels on nicoletone ltm, sleep, neeg, veeg or icu monitor systems.
  • Action
    An Advisory Notice, dated August 25, 2006, was sent to all affected customers. The notice described the issues, states to discontinue use of 5.20.1038 software until updated 5.21.1039c software is installed.

Device

Device Recall NicoletOne monitoring system version 5.20 software
  • Model / Serial
    NicoletOne Version 5.20 software released and installed after August 07, 2006.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
  • Product Description
    NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
  • Manufacturer
    Nicolet Biomedical Div of Viasys Healthcare

Manufacturer

Nicolet Biomedical Div of Viasys Healthcare
  • Manufacturer Address
    Nicolet Biomedical Div of Viasys Healthcare, 5225 Verona Rd, Madison WI 53711-4497
  • Source
    USFDA