Public recall detail

IOMAX Cortical Module

2024-05-07

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Recall Safety notice
Quick summary

Quick summary: IOMAX Cortical Module. Date: 2024-05-07.

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: 2024-05-07.

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 II
IdentificationRA-75489

Affected products

ProductIOMAX Cortical Module
Lot19029603AA0124001 19029603AA0224008 19029603AA0124002
Model190296-200
Serial number19029603AA0124001 19029603AA0224008 19029603AA0124002
DescriptionIOMAX Cortical Module

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

What you should do

  • Contact the manufacturer if you require additional information. Return affected devices to manufacturer for repair or replacement.
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 II
Alert / recall typeHealth product recall
Identification numberRA-75489
Background{}
CompaniesCadwell Industries, Inc. 909 North Kellogg Street, Kennewick, Washington, United States, 99336
AudiencesHealthcare
Source updated2024-05-07

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

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