FDA recall Z-1603-2024

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

Product

IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

Reason for recall

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Distribution

US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

Key facts

Status
Ongoing
Initiation date
2024-03-04
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ottignies-Louvain-La-Neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2024