Mega Soft Universal Patient Return Electrode
Brand(s)
Last updated
Summary
Product
Mega Soft Universal Patient Return Electrode
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. | 0840 |
Issue
Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries. The combination of these conditions may be more likely when the pad is used with infants and small children.
Recall Start Date: May 8, 2024
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-75521
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