FDASeptember 29, 2021device
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
coopersurgical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEndosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.2025-06-11
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- FDABrand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely re...2024-11-15
- FDABrand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos)...2024-11-15
- FDABrand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at clos...2024-11-15
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