Health product recall

IOMAX Cortical Module

Last updated

Summary

Product
IOMAX Cortical Module
Issue
Medical devices - Performance issue
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

IOMAX Cortical Module

19029603AA0224008
19029603AA0224006

190296-200

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies

Cadwell Industries, Inc.

909 North Kellogg Street, Kennewick, Washington, United States, 99336

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75561

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