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 B.V. Philips IQon, iCT, Ingenuity and Brilliance CT 64 systems [Software versions: 4.1.10.x and 4.7.7.x; Multiple product codes] [HKMD No.: 200454].
According to the TGA, the manufacturer has identified the following multiple software issues affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems. Issues include brighter preview images for standard resolution head scan, unable to load a customised Exam Card after upgrade, update acceptance and constancy test procedure, general slowness during stress validation test, certain ECG gated EC not possible after upgrade and neck scan types with high resolution, 0.67 mm thickness is incorrectly enabled.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00458-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 May 2023