Events

Recall of NicoletOne

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
    45328
  • Event Risk Class
    Class 3
  • Event Number
    Z-0126-2008
  • Event Initiated Date
    2007-09-11
  • Event Date Posted
    2008-01-03
  • 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=65273
  • 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
    Electroencephalograph - Product Code GWQ
  • Reason
    Display lock-up: viasys healthcare nicoletone icu monitor freezes up during operation when using the digital video option.
  • Action
    Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.

Device

NicoletOne
  • Model / Serial
    ON040060, ON050120, ON050130, ON050168, ON050186, ON050197, ON050199, ON050203, ON050206, ON050212, ON050220, ON050231, ON060232, ON060243, ON060254, ON060256, ON060257, ON060269, ON060270, ON060272, ON060275, ON060276, ON060277, ON060278, ON060279, ON060280, ON060288, ON060290, ON060291, ON060292, ON060299, ON070301, ON070308.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.
  • Product Description
    Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. || Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711
  • 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