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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 Unitsee related information
Date Initiated by FirmSeptember 05, 2006
Date PostedSeptember 19, 2006
Recall Status1 Terminated 3 on October 26, 2006
Recall NumberZ-1508-06
Recall Event ID 36253
510(K)NumberK020186 
Product Classification Electrosurgical Unit - Product Code GEI
ProductConmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
Code Information Serial Numbers: 06GGP 004, 06GGP 005, 06GGP 009, 06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru 030, 06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru 140, 06GGP 141 thru 144 ,,, 06FGP 022, 06FGP 023, 06FGP 029 thru 046, 06FGP 048 thru 056, 06FGP 062 thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106, 06FGP 107, 06FGP 110 thru 112 .
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
ActionDomestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
Quantity in Commerce44 units (domestic), 40 units (International)
DistributionWorldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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