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U.S. Department of Health and Human Services

Class 2 Device Recall Gryus SuperPulse

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  Class 2 Device Recall Gryus SuperPulse see related information
Date Initiated by Firm December 05, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-0841-04
Recall Event ID 27883
Product Classification Electrosurgical Radio Frequency Generator - Product Code GEI
Product Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.
Code Information Model 744000
Recalling Firm/
Manufacturer		 Gyrus Medical, Inc
6655 Wedgewood Road
Maple Grove MN 55311
For Additional Information Contact Mercedes Bayani
763-416-3000 Ext. 215
Manufacturer Reason
for Recall		 The generator may malfunction when used in close proximity to a monopolar generator.
FDA Determined
Cause 2		 Other
Action On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.
Quantity in Commerce 14
Distribution Nationwide throughout the United States.
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.
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