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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum 2000 Electrosurgical Generator

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  Class 2 Device Recall Quantum 2000 Electrosurgical Generator see related information
Date Initiated by Firm September 29, 2021
Create Date November 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-0261-2022
Recall Event ID 88648
510(K)Number K963653  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075
Code Information Serial Numbers: 0112010 0209001 0214002 0309031 0313007BFIX 0411002 0609010FIX 0710001 0711008 0713011C 0809009 0813032CFIX 091402 1013009C 1013015C 1109017 1214005 2015090019 2015110003 2016030001 2016040012 2016060016 2016090003 2016110002 2017010005 2017060010 2017080010 QTMAA-4-095 QTM-AB-10-149 QTM-M-4-102FIX W110954 W351106 W60413 0114011 0212004 0214007 0312021 0313010B 0413003B 0612001B 0710003 0711008FIX 0713018C 0811017 0813033C 1011010 1013010C 1014004 1111002 2015040009 2015090021 2015110004 2016030002 2016040015 2016060020 2016090004 2016110003 2017020004 2017060013 AFZFIX QTMAA4101 QTM-AB-12-164 QTMY-11-0201 W204996 W381180 W605041 0114013 0212008 0214008 0312024 0313011B 0511002 0612003B 0710008 0711009 0714007 0811021 0813034C 1011010FIX 1013011C 1109008 1213005C 2015060003 2015100004 2015110009 2016040001 2016040018 2016070003 2016090007 2016110004 2017030002 2017080002 ATM-AA-4-106 QTMAA-4-102 QTM-AB-12-165 QTMY-12-0208 W2A1022 W381192 W708311FIX 0115006 0212010 0215005 0312033 0409005 0511003 0612010B 0710008FIX 0712009B 0809004 0811021FIX 0814011FIX 1012006B 1013012C 1109014 1213006C 2015090012 2015100006FIX 2015110010 2016040002 2016060012 2016070007 2016090014 2016120002 2017030005 2017080003 GHILL QTMAA6116 QTMAB3067 QTMY70139 W2B1036 W604009  0115007 0214001 0215007 0313001B 0409006 0511003FIX 0612016B 0711006 0713001C 0809007 0813029C 0814012 1013006C 1013014C 1109015 1214003 2015090015 2015110001 2016020006 2016040007 2016060013 2016080002 2016110001 2017010002 2017030009 2017080006 IUY80207 QTMAA-6-116 QTM-AB-9135 W107893 W2C1054 W604013   
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
FDA Determined
Cause 2		 Component design/selection
Action CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take: This Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you. Please feel free to reach us at 203-601-5200 ext. 3300. Please complete this form and return it via email: recall@coopersurgical.com or fax to 203.601.9870 ATTN: Product Surveillance. CooperSurgical will arrange for a product repair after this form has been received. Firm issued additional letter for the product LP-10-220 as it was not included in the initial recall letter. The letter dated 10/18/21 distributed to international accounts only.
Quantity in Commerce 193 Units
Distribution US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HGI and Original Applicant = WALLACH SURGICAL DEVICES, INC.
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