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 posed a medical device safety alert concerning Siemens Healthcare GmbH Cios Spin, Cios Alpha, Cios Flow with VA30 [Product code: 11108110, 10308194 and 11105200] [HKMD No.: 190270, 210448].
According to the TGA, the manufacturer is informing about a potential issue with Cios VA30 systems. In 3D mode, information about image orientation regarding “laterality” (i.e., L = left / R = right) cannot be defined and saved with the clinical image by the user. Therefore, in 3D mode, the user could mix up the patient orientation regarding “laterality”.
In radiography modes SUB, DR, and DCM, the autostore function may be deactivated by the user; however, in 3D mode, the autostore function is activated by default and cannot be deactivated by the user.
Therefore, the user could accidentally forget to save the images manually and be forced to repeat image acquisition.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00892-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Oct 2023