Recall Z-2792-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
| Date | Aug 13, 2018 (initiated May 15, 2018) |
| Status | Terminated |
| Reason | If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient. |
| Root cause | Use error |
| Action | The firm sent letters in June 2018, informing their customers of the issue. The firm will send labels that can be applied to the product to remind them not to plug 2 active devices into the same channel at a time. Updated 08/13/19 Starting on 06/29/18, updated Medical Device Correction Notifications and labels were mailed via second day service. Customers were asked to complete and return Business Reply Forms. |
| Quantity | 8380 units |
| Distribution | Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR Megadyne Medical Products, Inc., Mar 24, 2005 |