Louvain La Neuve, N/A, Belgium
Ion Beam Applications S.A. recalls
26 recalls recorded since 2018, most recently on 3 February 2026. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls26
Ongoing (FDA)10
Terminated or completed16
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 February 2026
- 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 from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1497-2026
- IBA Proton Therapy System - PROTEUS 235
Ongoing Class II Medical devices
- Recall started
- 10 July 2024
- Reason
- Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
- Distribution
- IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2693-2024
- IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ongoing Class II Medical devices
- Recall started
- 8 July 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3089-2024
- IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- Distribution
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1945-2024
- IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ongoing Class II Medical devices
- Recall started
- 4 March 2024
- Reason
- There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
- Distribution
- US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1603-2024
- IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Ongoing Class II Medical devices
- Recall started
- 18 September 2023
- Reason
- The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
- Distribution
- Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0295-2024
- IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Ongoing Class II Medical devices
- Recall started
- 20 April 2022
- 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 than prescribed
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1205-2022
- Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ongoing Class II Medical devices
- Recall started
- 15 February 2022
- 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 modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
- Distribution
- IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0747-2022
- ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Terminated Class II Medical devices
- Recall started
- 29 November 2021
- Terminated
- 20 February 2024
- 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 in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
- Distribution
- IN USA: VA, OK, NJ, TN OUS: Czech Republic.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0466-2022
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Ongoing Class II Medical devices
- Recall started
- 14 June 2021
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2434-2021
- Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ongoing Class II Medical devices
- Recall started
- 26 May 2021
- 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 field may be delivered with an error in position
- Distribution
- FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2155-2021
- Proteus 235-Proton Therapy System
Terminated Class II Medical devices
- Recall started
- 17 July 2020
- Terminated
- 30 August 2021
- Reason
- IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
- Distribution
- US: VA OUS: Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2715-2020
- Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and o
Terminated Class II Medical devices
- Recall started
- 21 April 2020
- Terminated
- 1 September 2021
- 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 user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2773-2020
- Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and
Terminated Class II Medical devices
- Recall started
- 12 December 2018
- Terminated
- 15 April 2020
- Reason
- There is a risk of detachment of the Compact Gantry Rolling Floor.
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0698-2019
- Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with loca
Terminated Class II Medical devices
- Recall started
- 27 June 2018
- Terminated
- 20 May 2020
- 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 mistreatment for the patient.
- Distribution
- US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2470-2018
- Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other
Terminated Class II Medical devices
- Recall started
- 16 May 2018
- Terminated
- 16 October 2018
- 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 corrected position.
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2424-2018
- 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 patients with localized tumors and other conditions susceptible to treatment
Terminated Class II Medical devices
- Recall started
- 26 January 2018
- Terminated
- 27 April 2020
- 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 between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
- Distribution
- Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1477-2018
- Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Terminated Class II Medical devices
- Recall started
- 5 December 2017
- Terminated
- 29 March 2019
- 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.
- Distribution
- US Distribution to the states of : MA, FL, VA, PA, OK, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0934-2018
- Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of
Terminated Class II Medical devices
- Recall started
- 17 November 2017
- Terminated
- 14 June 2021
- Reason
- There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0938-2018
- Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Terminated Class II Medical devices
- Recall started
- 1 November 2017
- Terminated
- 29 March 2019
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) to: MI only and country of: France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0943-2018
- 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 ONE) is a medical device designed to produce and deliver a proton beam for the
Terminated Class II Medical devices
- Recall started
- 19 October 2017
- Terminated
- 2 April 2019
- Reason
- Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
- Distribution
- US Distribution to the state of :FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0931-2018
- Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the trea
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 29 March 2019
- Reason
- IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
- Distribution
- WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0930-2018
- Proteus 235, graphite block 8
Terminated Class II Medical devices
- Recall started
- 28 October 2016
- Terminated
- 9 August 2019
- Reason
- IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2109-2018
- 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy
Terminated Class II Medical devices
- Recall started
- 16 September 2016
- Terminated
- 8 February 2019
- 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.
- Distribution
- Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2139-2018, Z-2138-2018
- Proteus ONE and Proteus Plus
- 12C
Terminated Class II Medical devices
- Recall started
- 7 August 2016
- Terminated
- 25 March 2020
- Reason
- IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
- Distribution
- Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2173-2018
- Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may inclu
Terminated Class II Medical devices
- Recall started
- 11 April 2016
- Terminated
- 25 March 2020
- 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.
- Distribution
- Units were distributed to Korea and Jacksonville, FL.
- Recall number
- Z-2284-2018
- The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.