Health product recall

IOMAX Cortical Module

Last updated

Summary

Product
IOMAX Cortical Module
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Return affected devices to manufacturer for repair or replacement. 

 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

IOMAX Cortical Module

19029603AA0124001
19029603AA0224008
19029603AA0124002

190296-200

Issue

An assembly error was discovered on the cortical module (PN 190296-200). A cortical module insulator that is used to provide an electric barrier between circuit boards for TCS-9, ICS, and other internal parts was found to be installed incorrectly. The insulator provides clearance between safety critical components and incorrect installation does not meet the minimum creepage/air gap required to meet IEC 60601-1. 

Recall start date: April 23, 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 II
Identification number
RA-75489

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