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 Huntleigh Healthcare Ltd TEAM3A & TEAM3I Fetal Monitor [All Serial Numbers affected; Multiple item numbers] [HKMD No.: 210218].
According to the TGA, the manufacturer has become aware of a software vulnerability, which manifests as the fetal monitor’s touch screen freezing. This freeze disables the functions that are being displayed. Whilst the occurrence of this vulnerability is extremely rare and audio remains present throughout the screen freeze, user intervention is required to restart the fetal monitor which may lead to a delay of up to 45 seconds.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00308-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Apr 2023