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 Maquet Cardiopulmonary GmbH (Getinge Australia Pty Ltd) Rotaflow II System - Serial interface cable [Lot Number: 3000289870] [HKMD number: 240297].
According to the TGA, RS232 cable of the Rotaflow II does not comply with the IEC 60601-1 standard as the capacitor of the respective socket is designed for 300V rather than 500V AC required by the IEC 60601-1. When the required voltage was applied, the RS232 cable was damaged as a result. In the worst-case scenario, 17 mA could flow through the user's body this way (electrical shock through body).
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00741-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Aug 2024