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 Healthcare Centricity Universal Viewer Zero Footprint Client [HKMD number: 210471].
According to the TGA, a problem involving Centricity Universal Viewer Zero Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user is identified. This occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers.
Users continue to have access to all reports via in the Series Selector. However, since the latest addendum may not be shown by default in the ZFP Viewer, this could lead to potential misdiagnosis if a user relies only on the information in the original report and does not review the addended report.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00622-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 Aug 2024