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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgical, cutting & coagulation & accessories.

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  Class 2 Device Recall Electrosurgical, cutting & coagulation & accessories. see related information
Date Initiated by Firm April 21, 2006
Date Posted May 10, 2006
Recall Status1 Terminated 3 on February 26, 2009
Recall Number Z-0859-06
Recall Event ID 35283
510(K)Number K984552  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
Code Information Product Number: CTRF117 and CTRF220. Lot numbers: C4K101C thru C4K122C, C4K126C thru C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C, C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C, C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru C6A286C.
Recalling Firm/
Manufacturer		 Covidien LP
5920 Longbow Dr
Boulder CO 80301-3202
For Additional Information Contact
303-581-6773
Manufacturer Reason
for Recall		 Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.
FDA Determined
Cause 2		 Other
Action Consignees were notified by telephone followed by a fax on 04/21/2006.
Quantity in Commerce 137 units
Distribution Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.
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 = RADIONICS, INC.
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