IOMAX Cortical Module
Brand(s)
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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