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U.S. Department of Health and Human Services

Class 2 Device Recall Wallach Electrosurgical Generator

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  Class 2 Device Recall Wallach Electrosurgical Generator see related information
Date Initiated by Firm October 16, 2019
Create Date December 05, 2019
Recall Status1 Terminated 3 on June 30, 2020
Recall Number Z-0601-2020
Recall Event ID 84132
510(K)Number K963653  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product Quantam 2000 Electrosurgical Generator, Part number 909075-05.
Code Information Serial numbers: 2015120001-2015120030 2016030001-2016030030 2016040001-2016040018 2016050001-2016050030 2016060001-2016060020 2016070001-2016070040 2016080001-2016080006 2016090001-2016090016 2016110001-2016110008 2016120001-2016120006 2017010001-2017010008 2017020001-2017020009 2017030001-2017030011 2017040001-2017040008 2017060001-2017060015 2017080002 2017080006 2017080010
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		 Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.
FDA Determined
Cause 2		 Device Design
Action On October 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by certified mail with confirmed delivery receipt stating: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL QUANTUM 2000 ELECTROSURGERY GENERATOR Dear Valued CooperSurgical Customer, CooperSurgical has issued a Medical Device Recall for 219 serial numbers of its QUANTUM 2000 Electrosurgery Generator [CooperSurgical part numbers: 909075, 909075-05 and 909075-05W]. The QUANTUM 2000 Electrosurgery Generator is used for loop electrosurgical excision procedure (LEEP) also called the loop excision of the transformation zone (LLETZ). It utilizes a very thin wire powered by an electrosurgical power supply to provide a cervical tissue specimen. CooperSurgical is issuing this medical device recall due to the possibility that the cut, coagulate, or blend function may not operate with the use of the Foot Pedal (Part Number: 109686-1 ). The nonconformity was detected during a Service and Repair activity. The affected units will work as intended with the use of the Hand-Switch Pencil and Cord (Part Numbers: 395-310/LP-50-101) to activate the cut, coagulation, or blend functions by hand control rather than foot activation using the Foot Pedal. Failure of the device to cut, coagulate, or blend tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case, which can only be averted by using the cut, coagulation, or blend functions on the Hand-Switch Pencil. Please be aware that serious injuries could occur due to the failure mode associated with this Recall. There have not been any adverse events reported to CooperSurgical due to this potential issue. Our records indicate you have purchased the affected product serial number from CooperSurgical. This recall affects 219 serial numbers manufactured between January 11, 2016 and August 17, 2017 and a corrective action has been initiated to prevent future recurrence.
Quantity in Commerce 110
Distribution US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania.
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 = HGI and Original Applicant = WALLACH SURGICAL DEVICES, INC.
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