Public recall detail

IOMAX Cortical Module

2024-05-24

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Recall Safety notice
Quick summary

Quick summary: IOMAX Cortical Module. Date: 2024-05-24.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: IOMAX Cortical Module. Date: 2024-05-24.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCadwell Industries, Inc.
ProductIOMAX Cortical Module
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75561

Affected products

ProductIOMAX Cortical Module
Lot19029603AA0224008 19029603AA0224006
Model190296-200
Serial number19029603AA0224008 19029603AA0224006
DescriptionIOMAX Cortical Module

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesCadwell Industries, Inc. 909 North Kellogg Street, Kennewick, Washington, United States, 99336
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75561
Background{}
CompaniesCadwell Industries, Inc. 909 North Kellogg Street, Kennewick, Washington, United States, 99336
AudiencesHealthcare
Source updated2024-05-24

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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