Class 2 Device Recall MegaPower Electrosurgical Generator

• Date Initiated by Firm: May 15, 2018
• Date Posted: August 13, 2018
• Recall Status: Terminated on January 30, 2024
• Recall Number: Z-2792-2018
• Recall Event ID: 80327
• 510(K)Number: K050579
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
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• Recalling Firm/ Manufacturer: Megadyne Medical Products, Inc.; 11506 S State St; Draper UT 84020-9453
• For Additional Information Contact: 801-576-9669
• Manufacturer Reason for Recall: If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
• FDA Determined Cause: Use error
• Action: The firm sent letters in June 2018, informing their customers of the issue. The firm will send labels that can be applied to the product to remind them not to plug 2 active devices into the same channel at a time. Updated 08/13/19 Starting on 06/29/18, updated Medical Device Correction Notifications and labels were mailed via second day service. Customers were asked to complete and return Business Reply Forms.
• Quantity in Commerce: 8380 units
• Distribution: Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets
• 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