CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part number 909075-05. These devices may fail to coagulate tissue during surgery, requiring medical intervention to control bleeding.
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.
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators with part number 909075-05. These devices may not function properly with the Hand Switch, potentially causing prolonged surgery and requiring medical intervention to control bleeding.
The device may fail to coagulate tissue when used with the Hand Switch. This could lead to prolonged surgical procedures where bleeding must be controlled by medical staff, increasing the risk of complications.
Surgical professionals who use these devices during procedures are most at risk. Patients undergoing surgery with the recalled generators could experience uncontrolled bleeding.
Check for the part number 909075-05 on the device. Serial numbers listed in the recall include many 10-digit numbers starting with 02, 04, 06, 07, 09, 10, or 12 followed by numbers.
Identify the part number (909075-05) and serial numbers listed in the recall to confirm if your device is affected.
The Quantum 2000 Electrosurgical Generators may not operate correctly with the Hand Switch, potentially causing prolonged surgery and requiring medical intervention to control bleeding.
Check the part number and serial numbers listed in the recall to determine if your device is affected. No specific action is required beyond verification.
The hazard could lead to prolonged surgery and medical intervention for bleeding, but the recall does not specify a risk of serious injury or death.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0262-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0262-2022 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
