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Terminated

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

FDA Recall Z-2792-2018 · Posted 2018-08-13

Recalling FirmMegadyne Medical Products, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2018-05-15
Date Terminated2024-01-30
Product Quantity8380 units

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.

Firm 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.

Root Cause

Use error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050579MEGA POWER ELECTROSURGICAL GENERATORMegadyne Medical Products, Inc. · 2005-03-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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