| Class 2 Device Recall Evident MWA Generator | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = GEI
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