Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Siemens Healthcare GmbH Sensis, Sensis Vibe Hemo, Sensis Vibe Combo with VD12A software [UDI-DI : 4056869010137, 4056869010199, 4056869010205] [HKMD No.: 210006].

According to the TGA, the manufacturer has identified four potential issues with Sensis/Sensis Vibe systems:

• Issue 1: “PASSWORD STORE CORRUPTED” error message during system bootup;
• Issue 2: Subsystem crash during examination;
• Issue 3: Dialog Monitor Computer (DMC) application crash while loading a study;
• Issue 4: Software crash due to system internal timeout.

The potential high risks associated to the issue are the procedure might be delayed or the operation needs to be cancelled.

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01459-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 Nov 2022