FDA recall Z-3089-2024

Product

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Reason for recall

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Distribution

Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.

Key facts

Status

Ongoing

Initiation date

2024-07-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ottignies-Louvain-La-Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3089-2024