Recall Z-0600-2020 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075.
| Date | Oct 16, 2019 |
| Status | Terminated |
| Reason | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation. |
| Root cause | Device Design |
| Action | On October 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by certified mail with confirmed delivery receipt stating: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL QUANTUM 2000 ELECTROSURGERY GENERATOR Dear Valued CooperSurgical Customer, CooperSurgical has issued a Medical Device Recall for 219 serial numbers of its QUANTUM 2000 Electrosurgery Generator [CooperSurgical part numbers: 909075, 909075-05 and 909075-05W]. The QUANTUM 2000 Electrosurgery Generator is used for loop electrosurgical excision procedure (LEEP) also called the loop excision of the transf |
| Quantity | 105 |
| Distribution | US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM Wallach Surgical Devices, Inc., Jun 11, 1997 |