Mega Soft Electrodes
Brand(s)
Last updated
Summary
Product
Mega Soft Electrodes
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Mega Soft Universal Patient Return Electrode | All lots. | 0846 0845 |
| Mega Soft Universal Plus Patient Return Electrode | All lots. | 0847 |
| Mega Soft Dual Universal Plus Patient Return Electrode | All lots. | 0848 |
Issue
Megadyne has received reports of patient burns identified after surgical procedures in which mega soft pads were used. Megadyne is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age. We have conducted a thorough investigation, and have not identified any design or manufacturing defects, nor have we determined definitive root cause for the reports.
Recall Start Date: December 12, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Megadyne Medical Products Inc
4545 Creek Road, Cincinnati, Ohio, United States, 45242
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74766
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