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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Welch Allyn, Inc. Connex Spot Monitor [HKMD number: 210012].
According to the TGA, the manufacturer is providing a fix for a security vulnerability that has been found involving the Connex Spot Monitor (CSM). The manufacturer offered a routine software enhancement to address the vulnerability on 16 October 2023 under software patch version 1.52.01. The software patch includes additional controls for accessing the Advanced Settings and Debug Menu. These tools on the device require additional authentication to prevent access to the default key.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00527-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 Jul 2024