Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Cadwell Industries, Inc. IOMAX Cortical Module [Model or catalog number: 190296-200; Lot or serial number: 19029603AA0224008, 19029603AA0224006] [HKMD No.: 180275].
According to Health Canada, the manufacturer has identified 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.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/iomax-cortical-module-0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 25 May 2024
Posted on 27 May 2024