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Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

FDA Device Recall #Z-0263-2022 — Class II — September 29, 2021

Recall Summary

Recall Number Z-0263-2022
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 154 Units

Product Description

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

Reason for Recall

XXX

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: 0111001 0111003 0111004 0111005 0111006 0112001 0112002 0112003 0113001B 0113002B 0113003B 0113004B 0113005B 0113006B 0113007B 0113008B 0113010B 0114001 0114002 0114003 0114004 0114005 0114006 0114007 0114008 0114009 0114010 0209015 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0312001 0312002 0312009 0312009FIX 0312010 0312028 0413001B 0414001 0414003 0414004 0414008 0414014 0414018 0512001B 0512002B 0513001B 0513002B 0513003B 0514005 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0712001B 0712002B 0712003B 0712004B 0712005B 0712006B 0713001C 0713002C 0713003C 0713004C 0713005C 0713006C 0809001SYC 0813020C 0813021C 0813022C 0813023C 0813024C 0813025C 0814010 1012001B 1012002B 1012003B 1012004B 1012005B 1012006B 1012007B 1012008B 1012009B 1012010B 1109018 1109019 1113001C 1113002C 1113003C 1113004C 1113005C 1113006C 1113007C 1113008C 1113009C 1113010C 1213001 1213002 1213003 1214007 2015040001 2015040002 2015040003 2015040004 2015040005 2015050001 2015050002 2015060001 2015060002 2015060003 2015060004 2015060005 2015070004 2015090002 2015090003 2016050001 2016050005 2016070001 2016070002 2016070003 2016070004 2016070005 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2017060003 2017060005 QTM-AB-1-002 QTMAB-12-175

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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.

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