Home / Recalls / Medical Devices
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Recalled May 1, 2024 · FDA recall Z-1603-2024 · Ion Beam Applications S.A
Hazard
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. · FDA Class II
Units
8 units
Sold at
US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
Description
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Product
IBA Proton Therapy System - PROTEUS 235, 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 →