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 S.A. IBA Proton Therapy System – PROTEUS 235 [PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0.] [HKMD No.: 200375].
According to the FDA, the patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93293
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Nov 2023