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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/
Manufacturer
Conmed Electrosurgery
7211 South Eagle Street
Centennial CO 80112
For Additional Information Contact
303-269-8224
Manufacturer Reason
for Recall
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
FDA Determined
Cause 2
Other
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.
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