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 Gyrus ACMI, Inc. (Olympus) Soltive Premium SuperPulsed Laser System [Product Code: TFL-PLS] [HKMD Number: 220135].
According to the TGA, the manufacturer found that if the power cord used for the Soltive Laser device is non-compliant it may affect the performance of the device. Potential harms that may be associated with the use of a non-compatible power cord include burns or electrical shock to the user, or prolonged surgeries/cancellation of procedures.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00168-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Mar 2024