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CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Recalled November 24, 2021 · FDA recall Z-0261-2022 · CooperSurgical
Hazard
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 Class II
Units
193 Units
Sold at
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
Description
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.
Product
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →