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 Philips 3D9-3v Transducer (Accessory to Philips Ultrasound Systems : EPIQ Elite, Affiniti 30, 50, and 70, ClearVue 850, HD15, iU22, Compact 5000) [Multiple serial numbers] [HKMD No.: 070246, 100223, 140206, 140207, 150094, 200302].
According to TGA, the 3D9-3v Transducer chassis assembly consists of two parts that are bonded together. The bond between the front and rear parts of the chassis of these transducers may fail.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00662-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jul 2023
Updated on 25 Jul 2023