FDA recall Z-2284-2018

Ion Beam Applications S.A. · Class II · device

Product

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

Reason for recall

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

Distribution

Units were distributed to Korea and Jacksonville, FL.

Key facts

Status
Terminated
Initiation date
2016-04-11
Report date
2018-07-04
Termination date
2020-03-25
Voluntary/Mandated
—
Location
Louvain La Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2284-2018