Class 2 Device Recall Electrosurgical Unit

• Date Initiated by Firm: September 05, 2006
• Date Posted: September 19, 2006
• Recall Status: Terminated 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: 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