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. POWERSEAL Sealer and Divider [Model Number: PS-0523CJDA, PS-0537CJDA, PS-0544CJDA] [HKMD Number: 230177].
According to the TGA, the manufacturer has become aware of nine POWERSEAL units determined to be out of specification which may have resulted in the device not performing as expected.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00237-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Mar 2024