CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part number 909075 due to potential coagulation failure during surgery, requiring medical intervention for 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 specific serial numbers because the coagulation function might not work properly when using the Hand Switch. This could lead to prolonged surgery and bleeding that requires medical attention.
The device may fail to coagulate tissue when the Hand Switch is used, which can cause prolonged surgical procedures. This may result in significant bleeding that requires medical intervention to complete the surgery safely.
Surgical professionals and hospitals that own or use the Quantum 2000 Electrosurgical Generators with the listed serial numbers are most at risk. The hazard affects the coagulation function during surgery.
Check the serial number on the device. The affected units have specific serial numbers listed in the recall notice, including a range of numbers starting with 0112010 through W604013.
Identify the serial number on your Quantum 2000 Electrosurgical Generator to see if it matches the list of affected serial numbers provided in the recall.
The recall is due to the coagulation function potentially failing when using the Hand Switch, which could lead to prolonged surgery and bleeding requiring medical intervention.
Check the serial number against the list of affected numbers provided in the recall notice. If it matches, you should contact CooperSurgical for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should contact CooperSurgical for guidance.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0261-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0261-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
