Ion Beam Applications recalls
9 official recalls and safety alerts involving Ion Beam Applications since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ion Beam Applications or the relevant agency.
- 2026-03-18
USIon Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal…
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the state of FL and the countries of…Official notice →- 2024-09-18
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11…
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL,…Official notice → - 2024-08-28
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized…
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
FDA · DeviceIon Beam Applications S.A.IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy…Official notice → - 2024-06-12
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized…
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the state of Virginia and the…Official notice → - 2024-05-01
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
FDA · DeviceIon Beam Applications S.A.US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.Official notice → - 2023-11-22
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient…
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of Arkansas, Florida,…Official notice → - 2022-06-08
- US
Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose…
FDA · DeviceIon Beam Applications S.A.Worldwide distribution - US Nationwide distribution in the states of IL, VA,…Official notice → - 2022-03-16
- US
Ion Beam Applications S.A. recalls ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and…
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually…
FDA · DeviceIon Beam Applications S.A.IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England,…Official notice → - 2022-01-19
- US
Ion Beam Applications S.A. recalls Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical…