MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA device recall Z-2792-2018 · posted 2018-08-13 · Terminated
Recall details
- Recalling firm
- Megadyne Medical Products, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 8380 units
- Distribution
- Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets
- Date initiated
- 2018-05-15
- Date posted
- 2018-08-13
- Date terminated
- 2024-01-30
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEGA POWER ELECTROSURGICAL GENERATOR (K050579) | Megadyne Medical Products, Inc. | 2005-03-24 |