Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Reported: November 24, 2021 Initiated: September 29, 2021 #Z-0261-2022
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.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 193 Units
- Distribution
- 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
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075. Recalled by CooperSurgical, Inc.. Units affected: 193 Units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0261-2022.
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