MegaPower Electrosurgical Generator Recalled for Potential Patient Burns
Megadyne Medical Products is recalling 8,380 MegaPower Electrosurgical Generators because plugging two devices into the same port can activate both, potentially causing patient burns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of patient burns from a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Megadyne Medical Products, Inc. is recalling 8,380 units of the MegaPower Electrosurgical Generator (Product code 1000, GTIN 10614559103715). The recall was initiated because if two devices are plugged into the same channel or port in the generator, both devices will activate. If one device is left laying on the patient, the result could be burning of the patient.
The affected devices were distributed worldwide, including in the US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets. The recall covers a wide range of serial numbers, which are listed in the official FDA recall record Z-2792-2018.
Healthcare facilities and users should check their inventory for the MegaPower Electrosurgical Generator with the affected serial numbers. If a device is found, it should be removed from service and the manufacturer contacted for instructions on return or replacement.
The recalled product
- Product
- MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 8,380
Distribution
Distributed nationwide across the United States.
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