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 (PTS-10 versions, PTS-11 versions, and PTS-12 versions) [HKMD No.: 200375].
According to the FDA, there is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94297
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Apr 2024