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 Spectral CT7500 [Product codes: 728333 and 728340; Serial numbers: 10013 through to 10162, 396001, 396003, and 397002 through to 397014 respectively] [HKMD No.: 220236].
According to the TGA, the manufacturer has identified an issue with the Detector Measurement System (DMS) Power Supply Unit (PSU) on the Spectral CT7500 that could affect the performance of the CT system(s). For any scan type, there may be a disruption to the power supplied to the DMS. If this occurs it could result in recognisable artifacts in the image, which may result in a patient rescan being required.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00746-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Aug 2023