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 Philips Medical Systems DMC GmbH ProxiDiagnost N90 1.1 [Model Number: 706110; Multiple serial numbers] [HKMD No.: 210062].
According to the TGA, the manufacturer has identified two issues with the Philips ProxiDiagnost N90 1.1 system that could pose a risk for patients or users. Users may encounter one or both of the following issues: potential component damage due to short circuit and potential table stop due to a broken tabletop cable.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01494-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Dec 2022