Recall Z-2057-2019 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
| Date | Jun 18, 2019 |
| Status | Terminated |
| Reason | The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. |
| Root cause | Device Design |
| Action | The firm notified customers of the recall via Urgent Medical Device Recall letters dated June 18, 2019. Customers were informed that the device may fail to cut, coagulate, or blend tissue with use of the Foot Pedal. Serious injuries could occur due to this failure mode. Customers were instructed to do the following: - Use the Hand-Switch Pencil and Cord (Part Numbers: 395310/LP50101) to activate the cut, coagulation, or blend functions by hand control instead of foot action using the Foot Pedal. - Complete the acknowledgement and receipt form and return to the firm. If you have additional |
| Quantity | 358 |
| Distribution | Nationwide domestic distribution. International distribution to Canada and Costa Rica. |
| FDA record | Open on fda.gov |