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 Nederland BV Philips Big Bore RT, Brilliance CT Big Bore and Brilliance CT Big Bore Oncology (software version 4.8.0) [Product Code: 728242, 728244, 728243; UDI: (01)00884838095168, (01)00884838059450, (01)00884838059450] [HKMD No.: 200303].
According to the TGA, the manufacturer has identified multiple software issues affecting Philips Big Bore RT and Upgrade Brilliance CT Big Bore systems. These issues may cause the system to shut down unexpectedly or to generate unsatisfactory images, which may result in the need to perform a rescan.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00540-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Jun 2023