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 AMBU Australia Pty Ltd aView 2 Advance [Catalogue number: 405011000; Version number: 054, 055, 056, 058, 059; Serial number: A220100955] [HKMD No.: 190064].
According to the TGA, the manufacturer has received information where an Ambu aView 2 Advance has been dropped on the floor, short-circuited, and thereafter combusted. No patient or staff member was harmed, and the incident is regarded as an exceptionally rare case.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00722-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Aug 2023