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 [Versions 6.0 SP6 through SP11.4] [HKMD No.: 210471].
According to the TGA, the manufacturer has become aware of an issue where Distance and Area measurement values can display inaccurately on images in Centricity Universal Viewer Zero Footprint Client (ZFP) that are scaled down from their original resolution. There have been no injuries reported as a result of this issue.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00767-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jun 2022