FDA recall Z-2792-2018

Product

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

Reason for recall

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.

Distribution

Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets

Key facts

Status

Terminated

Initiation date

2018-05-15

Report date

2018-08-22

Termination date

2024-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Draper, UT, United States

Primary source

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