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 Siemens Medical Solutions USA, Inc. Symbia Pro.specta [Product codes: 11364751, 11364752 and 11364753] [HKMD No.: 220282].
According to the TGA, the manufacturer is informing users that there is a possibility that during a whole-body planar scan with auto-contour, the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed. This issue may occur when performing a whole-body planar scan with auto-contour turned on and the patient positioned with high knees, for example with a high knee rest. During the move to the start position, the SLD sensor may detect the knees resulting in detector 1 not moving as close to the patient as possible. This may lead to a reduction in image quality.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00642-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Jul 2023