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 Ultrasound, Inc. (Philips Electronics Australia Ltd) Philips EPIQ Series Ultrasound Systems [Systems manufactured between 18/09/2023 to 08/11/2023] [HKMD numbers: 140206, 140207, 200013].
According to TGA, the manufacturer has identified that Time Gain Compensation (TGC) Slide Controls may become unresponsive after multiple start-ups/reboots of the EPIQ Ultrasound System. Rebooting the system may not recover the TGC Slide Controls. TGC Slide Controls are used to make small 2D gain manipulations across the 2D image. Each of these Slide Controls are used to adjust the brightness range of gain compensation over a unique region of the 2D image.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00069-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Jan 2024