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U.S. Department of Health and Human Services

Class 2 Device Recall Evident MWA Generator

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  Class 2 Device Recall Evident MWA Generator see related information
Date Initiated by Firm February 06, 2009
Date Posted August 30, 2011
Recall Status1 Terminated 3 on August 30, 2011
Recall Number Z-3092-2011
Recall Event ID 59754
510(K)Number K011676  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301.

Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
Code Information Serial Numbers:  XP7K0101R to XP7K0120R, XP7L0121R to XP7L0140R, XP8B0141R to XP8B0167R, XP8C0168R to XP8C0231R, XP8D0232R to XP8D0320R, XP8E0321R to XP8E0390R, XP8F0391R to XP8F0485R, XP8H0578R to XP8H0615R, XP8I0626R to XP8I0660R, XP8J0661R to XP8J0690R, XP8L0701R to XP8L0730R. 
Recalling Firm/
Manufacturer		 Covidien, PLC
5920 Longbow Dr
Boulder CO 80301-3202
For Additional Information Contact
303-581-6773
Manufacturer Reason
for Recall		 Generator may deliver full power when a lower power is selected.
FDA Determined
Cause 2		 Component design/selection
Action Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.
Quantity in Commerce 357 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the 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 = VIVANT MEDICAL, INC.
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