Events

Recall of Device Recall INTELECT ADVANCED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chattanooga Corp 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
    46281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1227-2008
  • Event Initiated Date
    2007-12-17
  • Event Date Posted
    2008-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67116
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Muslce stimulator and therapeutic ultrasound with electromyography - Product Code MPH
  • Reason
    Device malfunction: causing electric shock and burn.
  • Action
    Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.

Device

Device Recall INTELECT ADVANCED
  • Model / Serial
    Serial numbers 1000 - 3993
  • Product Classification
    Physical Medicine Devices
  • Distribution
    Worldwide Distribution - including USA
  • Product Description
    INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
  • Manufacturer
    Chattanooga Corp Inc

Manufacturer

Chattanooga Corp Inc
  • Manufacturer Address
    Chattanooga Corp Inc, 4717 Adams Rd, Hixson TN 37343
  • Source
    USFDA