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.
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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