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Health Canada Medical devices

Mega Soft Electrodes

Issued December 20, 2023
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
Hazard description
Performance
Product
Product name
Mega Soft Electrodes
Reference
ID
RA-74766