Class 2 Device Recall Active Electrode Monitoring System

• Date Initiated by Firm: June 23, 2003
• Date Posted: July 24, 2003
• Recall Status: Terminated on November 06, 2003
• Recall Number: Z-1050-03
• Recall Event ID: 26604
• 510(K)Number: K000480
• Product Classification: electrosurgical electrode - Product Code GEI
• Product: EM2 NC AEM Monitor (NON-COM)
• Code Information: Catalog Number EM2 NC, all serial numbers.
• Recalling Firm/ Manufacturer: Encision, Inc.; 4828 Sterling Drive; Boulder CO 80301
• For Additional Information Contact: 303-444-2600
• Manufacturer Reason for Recall: Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
• FDA Determined Cause: Other
• Action: Accounts were visited by sales representatives beginning 6/23/2003.
• Quantity in Commerce: 21 units
• Distribution: CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI