Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Device Recall #Z-0261-2022 — Class II — September 29, 2021
Recall Summary
| Recall Number | Z-0261-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 29, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperSurgical, Inc. |
| Location | Trumbull, CT |
| Product Type | Devices |
| Quantity | 193 Units |
Product Description
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
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.
Distribution Pattern
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
Lot / 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
Other Recalls from CooperSurgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2137-2025 | Class II | Endosee System Convenience Kit with IV Tube. Mo... | Jun 11, 2025 |
| Z-2136-2025 | Class II | Endosee System Convenience Kit. Model Number: E... | Jun 11, 2025 |
| Z-2135-2025 | Class II | HSG Procedure Tray. Model Number: 6050T. Th... | Jun 11, 2025 |
| Z-0691-2025 | Class II | Brand Name: K-Systems Product Name: R65 Trolle... | Nov 15, 2024 |
| Z-0688-2025 | Class II | Brand Name: K-Systems Product Name: G85 Mini I... | Nov 15, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.