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 Spectral CT 7500 [Product codes: 728333 and 728340; Serial numbers: 396001, 396003, 397002, 397007 and between 10013 to 10135] [HKMD No.: 220236].
According to the TGA, the manufacturer has identified an issue where a scan could be interrupted with error messages when the room temperature is at the high end of the temperature range. If this issue occurs, all patient scan data prior to the shutdown can be restored. In some situations, a rescan may be needed.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00582-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Jun 2023