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 Medtronic Navigation Inc StealthStation S8 Application [Software name: SW APP 9735762 STEALTH S8 APP; Model number: 9735762; Version: 1.0.1, 1.0.2, 1.0.3, 1.1.0, 1.2.0] [HKMD Number: 210371].
According to the TGA, an anomaly related to the loss of text and numerical characters in the banner(s) of the software application impacts the cranial procedures within StealthStation S8 Application, versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. The software anomaly can cause numbers or letters to be ‘missing’ from the displayed text and to be replaced by a space instead in the 'Distance to Target' and 'Tip Stop Point' areas. All other navigation information on the screen is accurate, including active navigation images.
This anomaly is corrected in software version 1.3.0 and all subsequent versions.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00284-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Apr 2024