Megadyne Medical Products, Inc. recalls MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

Recall date

May 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2792-2018

FDA classification

Class II

Brand / firm

Megadyne Medical Products, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715