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 United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Siemens Healthcare GmbH Sensis Vibe systems with software version VD15B [Model Numbers: 10910620, 10765502, 6648161, 11007641] [HKMD number: 210006].
According to the FDA, if the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94956
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Jul 2024