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U.S. Department of Health and Human Services

Class 2 Device Recall Active Electrode Monitoring System

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  Class 2 Device Recall Active Electrode Monitoring System see related information
Date Initiated by Firm June 23, 2003
Date Posted July 24, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ELECTROSCOPE, INC.
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