Events

Recall of Device Recall Active Electrode Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encision, 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
    26604
  • Event Risk Class
    Class 2
  • Event Number
    Z-1050-03
  • Event Initiated Date
    2003-06-23
  • Event Date Posted
    2003-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27979
  • 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
    electrosurgical electrode - Product Code GEI
  • Reason
    Use of nc versions of aem monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
  • Action
    Accounts were visited by sales representatives beginning 6/23/2003.

Device

Device Recall Active Electrode Monitoring System
  • Model / Serial
    Catalog Number EM2 NC, all serial numbers.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
  • Product Description
    EM2 NC AEM Monitor (NON-COM)
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Manufacturer Address
    Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
  • Source
    USFDA