• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Quantum 2000 Electrosurgical Generator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Quantum 2000 Electrosurgical Generatorsee related information
Date Initiated by FirmSeptember 29, 2021
Create DateNovember 18, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0262-2022
Recall Event ID 88648
510(K)NumberK963653 
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
ProductQuantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
Code Information Serial Numbers:  0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024 0211025 0211026 0211027 0211028 0211029 0211030 0211031 0211032 0211033 0211034 0211035 0211036 0211037 0211038 0211039 0211040 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215020 0215021 0215022 0215023 0215024 0215025 0215026 0215027 0215028 0215029 0215030 0215031 0215032 0215033 0215034 0215035 0215036 0314014 0314014KF 0314019 0410001 0410002 0410003 0410004 0410005 0410006 0410007 0410008 0410009 0410010 0410011 0410012 0410013 0410014 0410015 0410016 0410017 0410018 0410019 0410020 0410021 0410022 0410023 0410024 0410025 0410026 0410027 0410028 0410029 0410030 0410031 0410032 0410033 0410034 0410035 0410036 0410037 0410038 0410039 0410040 0414009 0414010 0414011 0414013 0414015 0414016 0414019 0414021 0414023 0414024 0510001 0510002 0510003 0510004 0612001B 0612002B 0612003B 0612003BTP 0612004B 0612005B 0612006B 0612007B 0612008B 0612008BTP 0612009B 0612010B 0612011B 0612012B 0612013B 0612014B 0612015B 0612016B 0612017B 0612018B 0612019B 0612020B 0612021B 0612022B 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0612029B 0612030B 0612031B 0612032B 0612033B 0612034B 0612035B 0612036B 0612037B 0612038B 0612039B 0612040B 0613001C 0613002C 0613003C 0613004C 0613005C 0613006C 0613007C 0613008C 0613009C 0613010C 0613011C 0613012C 0613013C 0613014C 0613015C 0613016C 0613017C 0613018C 0613019C 0613020C 0613021C 0613022C 0613023C 0711001 0711002 0711003 0711004 0711005 0711006 0711007 0711008 0711009 0711010 0711011 0711012 0711013 0711014 0711015 0711016 0711017 0711018 0711019 0711020 0711022 0711023 0711024 0711025 0711027 0711028 0711029 0711030 0711031 0711032 0711033 0711034 0711035 0711036 0711037 0711038 0711039 0711040 0714001 0714002 0714003 0714004 0714004KF 0714005 0714006 0714007 0714008 0714009 0714009KF 0714010 0714011 0714012 0714013 0714014 0714015 0714016 0714017 0714018 0714019 0714020 0714021 0714022 0714023 0714024 0714025 0714026 0714027 0714028 0910012 0910013 0910014 0910015 0910016 0910017 0910018 0910019 0910020 0910021 0910022 0910023 0910024 0910025 0910026 0910027 0910028 0910029 0910030 0910031 0910032 0910033 0910034 0910035 0910036 0910037 0910038 0910039 0910040 0910041 0910042 0910043 0910044 0910045 0910046 0910047 0910048 0910049 0910050 0910051 0910052 0910053 0910054 0910055 0911002 0911003 1011001 1011002 1011003 1011004 1011005 1011006 1011007 1011008 1011009 1011010 1011011 1011012 1011013 1011014 1011015 1011016 1011017 1011018 1011019 1011020 1011021 1011022 1011023 1011024 1011025 1011026 1011027 1011028 1011029 1011030 1011031 1011032 1011033 1011034 1011035 1011036 1011037 1011038 1011039 1011040 1014001 1014002 1014003 1014004 1014004KF 1014005 1014006 1014007 1014008 1014009 1014010 1014011 1014011KF 1014012 1014013 1014014 1014015 1014016 1014017 1014018 1014019 1014020 1014020KF 1014021 1014022 1014023 1014024 1014025 1209005 1209006 1209007 1209008 1209009 1209010 1209011 1209012 1209013 1209014 1209015 1209016 1209017 1209018 1209019 1209020 1209021 1209022 1209023 1209024 1209025 1209026 1209027 1209028 1209029 1209030 1209031 1209032 1209033 1209034 1209035 1209036 1209037 1209038 1209039 1209040 1209041 1209042 1209043 1209044 1212001B 1212002B 1212003B 1212004B 1212005B 1212006B 1212007B 1212008B 1212008BTP 1212009B 1212010B 1212011B 1212012B 1212013B 1212014B 1212015B 1212016B 1212017B 1212018B 1212019B 1212020B 1212021B 1212022B 1212023B 1212024B 1212025B 2015030001 2015030002 2015050001 2015050002 2015050003 2015050004 2015050005 2015050006 2015050007 2015050008 2015050009 2015050010 2015050011 2015050012 2015050013 2015050014 2015050015 2015050016 2015050017 2015050018 2015050019 2015050020 2015050021 2015050022 2015050023 2015050024 2015050025 2015050026 2015050027 2015050028 2015050029 2015050030 2015050031 2015050032 2015050033 2015050034 2015050035 2015050036 2015050037 2015060001 2015060002 2015060003 2015060004 2015060005 2015060006 2015070001 2015070002 2015070003 2015070005 2015070006 2015070007 2015080001 2015080002 2015080003 2015080004 2015080005 2015080006 2015080007 2015080008 2015080009 2015080010 2015080011 2015080012 2015080013 2015080014 2015080015 2015080016 2015080017 2015080018 2015080019 2015080020 2015080021 2015080022 2015080023 2015080024 2015080025 2015090001 2015090002 2015090003 2015090004 2015090005 2015120001 2015120002 2015120003 2015120004 2015120005 2015120006 2015120007 2015120008 2015120009 2015120010 2015120011 2015120012 2015120013 2015120014 2015120015 2015120016 2015120017 2015120018 2015120019 2015120020 2015120021 2015120022 2015120023 2015120024 2015120025 2015120026 2015120027 2015120028 2015120029 2015120030 2016030001 2016030002 2016030003 2016030004 2016030005 2016030006 2016030007 2016030008 2016030009 2016030010 2016030011 2016030012 2016030013 2016030014 2016030015 2016030016 2016030017 2016030018 2016030019 2016030020 2016030021 2016030022 2016030023 2016030024 2016030025 2016030026 2016030027 2016030028 2016030029 2016030030 2016050001 2016050002 2016050003 2016050004 2016050005 2016050006 2016050007 2016050008 2016050009 2016050010 2016050011 2016050012 2016050013 2016050014 2016050015 2016050016 2016050017 2016050018 2016050019 2016050020 2016050021 2016050022 2016050023 2016050024 2016050025 2016050026 2016050027 2016050028 2016050029 2016050030 2016070001 2016070002 2016070003 2016070004 2016070005 2016070021 2016070022 2016070023 2016070024 2016070025 2016070026 2016070027 2016070028 2016070029 2016070030 2016070031 2016070032 2016070033 2016070034 2016070035 2016070036 2016070037 2016070038 2016070039 2016070040 B041201 QTM-AB-1-003   
Recalling Firm/
Manufacturer
CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer 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
ActionCooperSurgical 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 Commerce700 Units
DistributionUS 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 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 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) Database510(K)s with Product Code = HGI
-
-