Company: Ion Beam Applications S.A.
Date of Enforcement Report 7/4/2018
Class II:

PRODUCT
The Proton Therapy System – Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) Recall Number: Z-2284-2018

REASON
TBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A.., Louvain La Neuve, Belgium on 4/11/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
Korea and Jacksonville, FL.