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 PageWriter TC30/50/70 Cardiographs [Product Numbers: 860306, 860310, 860315, 860429, 453564659341, 453564659351, 453564659331, 453564659321] [HKMD No.: 100144, 100147, 100157].
According to the TGA, the manufacturer has identified that during manufacturing process, a limited number of 12-lead and 16-lead Patient Interface Modules were potentially mislabelled.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00534-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Jun 2023