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 C1, T1, MR1 Ventilators [Part numbers: HMT-161001, HMT-161006 and HMT-161010; Serial numbers: xxxx = SN 6000, xxxx = SN 3000 and xxxx = SN 2000] [HKMD No.: 170303, 200322, 200331].
According to the TGA, the manufacturer found that in some rare cases, HAMILTON-C1/T1/MR1 ventilators do not complete the boot sequence upon initial startup. After pressing the power key, the ventilator display remains blank (black screen), generating an audible alarm without completing the boot sequence.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00578-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 Jul 2023