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 ACUSON Redwood 2.0 ultrasound systems - 18L6 transducer [Product code: 11503314] [HKMD No.: 210117].
According to TGA, if a user-generated preset for an 18L6 transducer created on an ACUSON Redwood 1.0 system is used with an ACUSON Redwood 2.0 system, the ACUSON Redwood 2.0 system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format (side by side) visualisation function.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00657-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jul 2023