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 [HKMD No.: 200454].
According to the TGA, the manufacturer has identified multiple software defects affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems. Investigation commenced due to complaints relating to the Bolus Tracking (BT) Algorithm. The BT was observed to perform extra shots after the threshold was reached in two separate incidents.
These defects may lead to hazards including patient exposure to radiation energy/ accidental or unwanted ionizing radiation.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00300-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 May 2024