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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgical Unit

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  Class 2 Device Recall Electrosurgical Unit see related information
Date Initiated by Firm September 05, 2006
Date Posted September 19, 2006
Recall Status1 Terminated 3 on October 26, 2006
Recall Number Z-1507-06
Recall Event ID 36253
510(K)Number K020135  
Product Classification Electrosurgical Unit - Product Code GEI
Product Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation
Code Information Serial numbers: 06GGN 001 thru 009, 06FGN 001 thru 010.
Recalling Firm/
Conmed Electrosurgery
7211 South Eagle Street
Centennial CO 80112
For Additional Information Contact
Manufacturer Reason
for Recall
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
FDA Determined
Cause 2
Action Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
Quantity in Commerce 19 units (International)
Distribution Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
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 = CONMED CORP.