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Ion Beam Applications S.A.
Ion Beam Applications S.A.: 36 FDA recall reports
Every medical device recall the FDA has published for Ion Beam Applications S.A.. The fault, and how the agency graded it.
36Reports
0Class I
10Ongoing
2026-03-18Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
IBA Proton Therapy System - PROTEUS 235
Z-1497-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- 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.
- Product
- IBA Proton Therapy System - PROTEUS 235
- Where it went
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- How much
- 4 units (1 US, 3 OUS)
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-1
Z-3089-2024 · Class II · reported 2024-09-18 · Ongoing
- Why it was recalled
- 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
- Where it went
- 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.
- How much
- 35 units
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of pa
Z-2693-2024 · Class II · reported 2024-08-28 · Ongoing
- Why it was recalled
- Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
- Product
- 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
- Where it went
- IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
- How much
- 19 units
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of p
Z-1945-2024 · Class II · reported 2024-06-12 · Ongoing
- Why it was recalled
- Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- Product
- 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.
- Where it went
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- How much
- 2 units
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Z-1603-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- 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.
- Where it went
- US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
- How much
- 8 units
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Confi
Z-0295-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
- Product
- IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
- Where it went
- 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.
- How much
- 5 (US), 9 (OUS)
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with lo
Z-1205-2022 · Class II · reported 2022-06-08 · Ongoing
- Why it was recalled
- 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
- Product
- 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
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- How much
- 4 units
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with l
Z-0747-2022 · Class II · reported 2022-03-16 · Ongoing
- Why it was recalled
- 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
- Product
- 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
- Where it went
- 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,
- How much
- 15 units US; 22 units OUS
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Z-0466-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- 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.
- Product
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Where it went
- IN USA: VA, OK, NJ, TN OUS: Czech Republic.
- How much
- 5 devices
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors
Z-2434-2021 · Class II · reported 2021-09-15 · Ongoing
- Why it was recalled
- Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
- Product
- 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
- Where it went
- 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.
- How much
- 27 worldwide, 11 in U.S.
Proteus 235-Proton Therapy System
Z-2155-2021 · Class II · reported 2021-08-04 · Ongoing
- Why it was recalled
- 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
- Product
- Proteus 235-Proton Therapy System
- Where it went
- FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
- How much
- 5 US; 8 OUS
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical
Z-2773-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- 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...
- Product
- 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 other conditions susceptible to treatment by radiation.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.
- How much
- 4 units
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical
Z-2715-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
- Product
- 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 other conditions susceptible to treatment by radiation.
- Where it went
- US: VA OUS: Belgium
- How much
- 2 Units
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus
Z-0698-2019 · Class II · reported 2019-01-16 · Terminated
- Why it was recalled
- There is a risk of detachment of the Compact Gantry Rolling Floor.
- Product
- 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 localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
- How much
- 7
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device
Z-2470-2018 · Class II · reported 2018-07-25 · Terminated
- Why it was recalled
- 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.
- Product
- 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 conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
- How much
- 14
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a
Z-2424-2018 · Class II · reported 2018-07-18 · Terminated
- Why it was recalled
- 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.
- Product
- 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 by radiation.
- Where it went
- Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
- How much
- 3 units
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Mana
Z-2284-2018 · Class II · reported 2018-07-04 · Terminated
- Why it was recalled
- IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
- Product
- The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
- Where it went
- Units were distributed to Korea and Jacksonville, FL.
- How much
- 2
Proteus ONE and Proteus Plus
Z-2139-2018 · Class II · reported 2018-06-20 · Terminated
- Why it was recalled
- 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.
- Product
- Proteus ONE and Proteus Plus
- Where it went
- Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
- How much
- N/A
12C
Z-2138-2018 · Class II · reported 2018-06-20 · Terminated
- Why it was recalled
- 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.
- Product
- 12C
- Where it went
- Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
- How much
- S0 Units
Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment o
Z-2173-2018 · Class II · reported 2018-06-20 · Terminated
- Why it was recalled
- IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
- Product
- 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 include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
- How much
- 19 units
12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged pa
Z-2109-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
- Product
- 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 equipment and to provide correction feedback to the radiation therapy system.
- Where it went
- 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.
- How much
- 5 units (12C)
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with
Z-1477-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- 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.
- Product
- 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.
- Where it went
- Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.
- How much
- 5
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand n
Z-0943-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
- Product
- 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 treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- Worldwide Distribution: US (nationwide) to: MI only and country of: France.
- How much
- 3
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the tre
Z-0938-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
- Product
- 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.
- Where it went
- Nationally
- How much
- 37
Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus
Z-0934-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- 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.
- Product
- 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 patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- US Distribution to the states of : MA, FL, VA, PA, OK, TN
- How much
- 14
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names
Z-0931-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
- Product
- 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 treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- US Distribution to the state of :FL
- How much
- 3
Proteus 235, graphite block 8
Z-0930-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
- Product
- Proteus 235, graphite block 8
- Where it went
- WA
- How much
- 3
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical dev
Z-2684-2017 · Class II · reported 2017-07-12 · Terminated
- Why it was recalled
- Software issue
- Product
- Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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 include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Where it went
- Distributed to FL, VA, IL, NJ, WA and South Korea
- How much
- 6 worldwide and 5 in the U.S.
Proteus 235 and Proteus ONE proton therapy systems
Z-2672-2017 · Class II · reported 2017-07-12 · Terminated
- Why it was recalled
- Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
- Product
- Proteus 235 and Proteus ONE proton therapy systems
- Where it went
- Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
- How much
- 18 worldwide and 10, in the U.S.
Proteus 235
Z-2592-2017 · Class II · reported 2017-06-28 · Terminated
- Why it was recalled
- 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 not irradiating between layers.
- Product
- Proteus 235
- Where it went
- Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
- How much
- 18 systems ( 10 in the US)
Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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