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 Ion Beam Applications SA IBA Proton Therapy System - PROTEUS 235, ProteusPLUS and ProteusONE [Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions] [HKMD No.: 200375].
According to the FDA, safety Parameters Verification Mechanisms can be deactivated in clinical runtime.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95080
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Sep 2024