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 GE Vingmed Ultrasound A/S Vivid S60 / Vivid S70 / Vivid S60N / Vivid S70N Ultrasound Systems [Vivid S60: v203, v204; Vivid S70: v203, v204; Vivid S60N: v203, v204, v205, v206; Vivid S70N: v203, v204, v205, v206] [HKMD No.: 220381].
According to the TGA, the manufacturer is informing users that certain Vivid ultrasound systems may not boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00526-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jun 2023