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 Incisive CT & CT 3500 System [Model numbers: 728143, 728144, 728148, 728149 and 728134, Multiple serial numbers] [HKMD No.: 180534].
According to TGA, the manufacturer has identified an issue with the Precise Position option installed with Incisive CT & CT 3500 systems, which may result in incorrect image orientation (i.e., flipped or reversed images). If the auto-detected patient orientation is incorrect and is unnoticed by the operator prior to scanning, the resulting images may be flipped or reversed.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00409-1.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 May 2023