FDA-Device2018-08-22Class II

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

Megadyne Medical Products, Inc.
Hazard

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.

Sold states
Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets
Affected count
8380 units
Manufactured in
11506 S State St, Draper, UT, United States
Products
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2792-2018

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