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Health Canada Medical devices

IOMAX Cortical Module

Issued May 24, 2024
Issue
A manufacturing defect on some printed circuit board assemblies (PCBAs) within a single lot of PCBAs may cause damage to other internal components during assembly which may result in unintended electrical stimulation when using the transcranial stimulator and low current stimulator during the same procedure. IOMAX cortical modules manufactured between 02/15/2024 and 05/07/2024 may have been shipped with the defective printed circuit board. Recall start date: May 17, 2024
Hazard description
Performance
Product
Product name
IOMAX Cortical Module
Reference
ID
RA-75561