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 Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning GE Vingmed Ultrasound A/S, Vscan Air CL, App versions 1.1.27 or earlier, UDI numbers 00840682147491, 00840682147484, 00840682147460, 00195278370501 and 00195278021601 [HKMD No.: 210396].
According to the TGA, the manufacturer recently identified through internal testing that Vscan Air CL does not fully meet one of the sections of the International Electrical Standard, IEC 60601-2-37. This section of the standard is regarding the maximum temperature limit for the probe in a test scenario in which the probe is scanning in the air continuously for 20 minutes with no gel applied.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00227-1.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Mar 2023