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.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Cadwell Industries, Inc. Cascade IOMAX Cortical Module [Model / Catalogue No.: 190296-20] [HKMD number: 180275].
According to the MHRA, 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.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/XfIZAkAdzyFaSkO7
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 May 2024