Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions

Recalled September 18, 2024 · FDA recall Z-3089-2024 · Ion Beam Applications S.A

Hazard

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime · FDA Class II

Units

35 units

Sold at

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.

Description

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

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

Manufacturer(s)

Ion Beam Applications S.A.

Made in

Belgium

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →