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 Siemens Healthcare GmbH Sensis and Sensis Vibe Combo systems with software version VD12A [HKMD No.: 210006].
According to the TGA, the manufacturer has become aware of an issue that with Sensis/Sensis Vibe VD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available. The system will no longer be available for patient treatment due to no communication with the ComboBox.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00821-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Jun 2022