Events

Recall of VIASYS Healthcare Disposable Surface Electrodes

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
    35416
  • Event Risk Class
    Class 3
  • Event Number
    Z-1254-06
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2006-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46028
  • 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
    Disposable Surface Electrodes - Product Code GXZ
  • Reason
    The bar electrodes do not meet performance specification for electrode impedance. a manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. these possible lower amplitudes will be measured only if the bar electrode is used as a bar.
  • Action
    Communication on April 28, 2006 by phone, followed by Certified Mail, with return receipt to confirm receipt of information . The letter describes the issue and asks that affected product be returned. The customer notification allows the user the option of using the Bar Electrode as 2 separate electrodes, as described in the Instructions for Use.

Device

VIASYS Healthcare Disposable Surface Electrodes
  • Model / Serial
    Lot 604664
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland
  • Product Description
    VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes
  • 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