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 No.: 190296-200; UDI/DI: 00840067100653,; Serial No.: 19029603AA0124014, 19029603AA0224009] [HKMD number: 180275].
According to the MHRA, 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, LCS, 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. IOMAX Cortical Modules manufactured between 12/12/2023 and 2/15/2024 may have been shipped with the insulator installed incorrectly.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/L7vahhceP3cEyK81
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 May 2024