Ion Beam Applications recalls
Ion Beam Applications appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-18.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 36 |
|---|---|
| Published | 2014-04-30 to 2026-03-18 |
| By agency | FDA Device (36) |
| By classification | Class II (36) |
| By status | terminated (26), ongoing (10) |
| Distribution named in notices | FL, IL, IN, KS, LA, MA, MI, NJ, OK, PA, TN, TX, US, VA, WA |
Recalls
- IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2026-03-18 · Ion Beam Applications
Reason: 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 fr… - IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and…
FDA Device · Class II · 2024-09-18 · Ion Beam Applications
Reason: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime - IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-08-28 · Ion Beam Applications
Reason: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues - IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-06-12 · Ion Beam Applications
Reason: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances - IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Device · Class II · 2024-05-01 · Ion Beam Applications
Reason: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. - IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2023-11-22 · Ion Beam Applications
Reason: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. - Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other condi…
FDA Device · Class II · 2022-06-08 · Ion Beam Applications
Reason: 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 th… - ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other con…
FDA Device · Class II · 2022-03-16 · Ion Beam Applications
Reason: 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 modif… - Proteus 235
FDA Device · Class II · 2022-01-19 · Ion Beam Applications
Reason: 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 processes… - Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept…
FDA Device · Class II · 2021-09-15 · Ion Beam Applications
Reason: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment - Proteus 235-Proton Therapy System
FDA Device · Class II · 2021-08-04 · Ion Beam Applications
Reason: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment fi… - Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and…
FDA Device · Class II · 2020-08-19 · Ion Beam Applications
Reason: Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the u… - Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and…
FDA Device · Class II · 2020-08-05 · Ion Beam Applications
Reason: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. - Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed…
FDA Device · Class II · 2019-01-16 · Ion Beam Applications
Reason: There is a risk of detachment of the Compact Gantry Rolling Floor. - Proteus 235, Universal Nozzle with snout 300x400
FDA Device · Class II · 2018-07-25 · Ion Beam Applications
Reason: Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mis… - Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of…
FDA Device · Class II · 2018-07-18 · Ion Beam Applications
Reason: Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the correcte… - The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
FDA Device · Class II · 2018-07-04 · Ion Beam Applications
Reason: IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. - Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors a…
FDA Device · Class II · 2018-06-20 · Ion Beam Applications
Reason: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. - 12C
FDA Device · Class II · 2018-06-20 · Ion Beam Applications
Reason: IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. - Proteus ONE and Proteus Plus
FDA Device · Class II · 2018-06-20 · Ion Beam Applications
Reason: IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. - 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy…
FDA Device · Class II · 2018-06-13 · Ion Beam Applications
Reason: IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem. - Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other c…
FDA Device · Class II · 2018-05-02 · Ion Beam Applications
Reason: When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch… - Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with local…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications
Reason: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. - Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus O…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications
Reason: The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. - Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medi…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications
Reason: An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate. - Proteus 235, graphite block 8
FDA Device · Class II · 2018-03-14 · Ion Beam Applications
Reason: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader - Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)…
FDA Device · Class II · 2018-03-14 · Ion Beam Applications
Reason: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. - Proteus 235 and Proteus ONE proton therapy systems
FDA Device · Class II · 2017-07-12 · Ion Beam Applications
Reason: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. - Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliv…
FDA Device · Class II · 2017-07-12 · Ion Beam Applications
Reason: Software issue - Proteus 235
FDA Device · Class II · 2017-06-28 · Ion Beam Applications
Reason: It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is no… - Proton therapy system -Proteus 235 aka Proteus Plus
FDA Device · Class II · 2017-05-24 · Ion Beam Applications
Reason: A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. - Proteus 235, Proton Therapy System
FDA Device · Class II · 2017-04-26 · Ion Beam Applications
Reason: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. - Proteus 235
FDA Device · Class II · 2017-04-05 · Ion Beam Applications
Reason: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. - adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for loc…
FDA Device · Class II · 2014-12-31 · Ion Beam Applications
Reason: Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific… - Proteus 235 Proton Therapy System for cancer treatment
FDA Device · Class II · 2014-11-05 · Ion Beam Applications
Reason: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to acceler… - Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116
FDA Device · Class II · 2014-04-30 · Ion Beam Applications
Reason: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).