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.
TGA has issued a medical device safety alert concerning RaySearch Laboratories AB (publ) RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B including some service packs [Build Numbers: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483] [HKMD: 180268]
According to TGA, an issue has been found with the display of the secondary image sets in a side-by-side view in RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B including some service packs. The primary image set may be displayed instead of the secondary image set. A 4D image set can be shown as a “cine loop”, running through the 3D image sets as a sequence. If a cine loop is started in the view of the primary image set, the same cine loop will be displayed in all side-by-side views, i.e., also in the view of the secondary image set, regardless of which image set is selected as secondary.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00134-1.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Jan 2022