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 GE Medical Systems Information Technologies, Inc. MAC VU360 V1.02 SP05 12 Lead ECG Post Acquisition Preview Screen [Product number: 2030360-001] [HKMD Number: 190177, 230116].
According to the TGA, on the MAC VU360 software version V1.02 SP05, after performing a 12 Lead ECG Acquisition, a filter is applied post-acquisition on the Preview Screen or Print Out report. There is the potential that the amplitude could be slightly reduced for QRS waves.
A new software version MACVU360 1.02 SP06 has been released to fix the reported issue on affected devices.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00169-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Mar 2024