The Recall Desk

Manufacturer

Ion Beam Applications S.A.

36 recalls in our database name Ion Beam Applications S.A. as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
4
Most recent
2026-03-18

Of the 36 recalls from Ion Beam Applications S.A. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (11%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 36

  • HighFDA (Devices)·Z-1497-2026·2026-03-18

    IBA proton therapy system may not interrupt beam when gating fails

    Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.

    Product
    IBA Proton Therapy System - PROTEUS 235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2024·2024-09-18

    Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled

    The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2024·2024-08-28

    IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

    FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.

    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
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1945-2024·2024-06-12

    Proton Therapy System May Continue Irradiation When Accelerator Control Parameters Out of Tolerance

    Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2024·2024-05-01

    Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation

    IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.

    Product
    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2024·2023-11-22

    IBA Proton Therapy System Patient Positioning Can Move Unexpectedly

    The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2022·2022-06-08

    Proton Therapy System Delivers Incorrect Radiation Dose in First Layer

    The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2022·2022-03-16

    Proton Therapy Systems May Fail to Verify Beam Range After Pause

    Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.

    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
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0466-2022·2022-01-19

    Proton Therapy System software startup allows test processes to contaminate clinical environment

    The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.

    Product
    Proteus 235; Version: PTS-8 versions before PTS-8.7.2
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2434-2021·2021-09-15

    Proteus 235 Proton Therapy System May Display Misleading Popup Message

    Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2021·2021-08-04

    Proteus 235-Proton Therapy System May Deliver Unintended Radiation

    The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.

    Product
    Proteus 235-Proton Therapy System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2020·2020-08-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.

    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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0698-2019·2019-01-16

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to 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 b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2470-2018·2018-07-25

    Ion Beam Applications Recalls Proteus 235 Nozzles Due to Crushing Risk

    Ion Beam Applications is recalling 14 Proteus 235 nozzles because they may allow gantry rotation or proton irradiation when accessories are not correctly positioned, posing a risk of crushing or mistreatment.

    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 ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2018·2018-07-18

    Proteus 235 Proton Beam Device Recalled for Correction Vector Loss

    Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2018·2018-07-04

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is voluntarily recalling two Proteus 235 Proton Therapy Systems to address a software issue and reduce associated risks.

    Product
    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2139-2018·2018-06-20

    Ion Beam Applications Recalls Proteus ONE and Plus Devices

    Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.

    Product
    Proteus ONE and Proteus Plus
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2173-2018·2018-06-20

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 19 Proteus 235 proton therapy systems to provide safety information to maintenance technicians regarding 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 treatm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    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 radiati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1477-2018·2018-05-02

    Ion Beam Applications Recalls Proteus Proton Beam Therapy Systems

    Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.

    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.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0938-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment 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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0943-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems because the internal configuration of electrometers and control boards 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 condit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 14 Proteus 235 proton therapy systems because an accessory can be improperly inserted, allowing the device to operate incorrectly.

    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 suscepti
    Category
    Medical Device
    Distribution
    6 states