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 Hamilton Medical AG HAMILTON-C1 AND HAMILTON-T1 VENTILATORS [Product Codes: HMT-161001, HMT-1610010, HMT-161006, HMT-1610060] [HKMD No.: 170303].
According to the TGA, the power cable currently in use for the Hamilton Medical ventilators HAMILTON-C1 and HAMILTON-T1 in Australia is not in line with the standard IEC 60601-1 and the local Australian requirements. The device should be used with the power cable type H05.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-01014-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Nov 2024