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 DMC GmbH Philips DigitalDiagnost, ProxiDiagnost, and CombiDiagnost systems [Reference Number: 712031, 712032, 712033, 712084, 712034, 712035, 712234, 712235, 709030, 709031, 706100, 706110] [HKMD No.: 100258, 210062]
According to the TGA, the manufacturer is advising that the system audio signal will be disabled, and no sound will be present when an exposure is terminated if the user follows either of the below sequences involving switching the system to STANDBY. The exposure image will still appear on the monitor even though there is no sound.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00200-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Mar 2023
Updated on 13 Mar 2023