Recall Z-2792-2018— Megadyne Medical Products, Inc.

Name: FDA recall Z-2792-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-15

Class II · Terminated

Class II FDA medical device recall by Megadyne Medical Products, Inc., initiated 2018-05-15, terminated 2024-01-30. It names one FDA 510(k) clearance: K050579. Product: MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715. 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..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-15
Terminated: 2024-01-30
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K050579 — MEGA POWER ELECTROSURGICAL GENERATORMegadyne Medical Products, Inc.·cleared 2005-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.