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.

26–36 of 36

  • HighFDA (Devices)·Z-0931-2018·2018-03-14

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems in Florida due to potential energy range discrepancies in the first layer of irradiation plans.

    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
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2684-2017·2017-07-12

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue

    Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.

    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
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2672-2017·2017-07-12

    Ion Beam Applications Recalls Proteus Proton Therapy Systems for Software Issues

    Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.

    Product
    Proteus 235 and Proteus ONE proton therapy systems
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2592-2017·2017-06-28

    Ion Beam Applications Recalls Proteus 235 Medical Devices

    Ion Beam Applications S.A. is recalling 18 Proteus 235 systems due to potential dark current issues in Pencil Beam Scanning mode.

    Product
    Proteus 235
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2097-2017·2017-05-24

    Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.

    Product
    Proton therapy system -Proteus 235 aka Proteus Plus. 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-1830-2017·2017-04-26

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.

    Product
    Proteus 235, Proton Therapy System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0836-2015·2014-12-31

    Ion Beam Applications Recalls adaPT insight Software Due to Calibration Error

    Ion Beam Applications S.A. is recalling one unit of adaPT insight software in Pennsylvania due to a calibration file error and a gantry collision incident.

    Product
    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 localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0020-2015·2014-11-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.

    Product
    Proteus 235 Proton Therapy System for cancer treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1492-2014·2014-04-30

    Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software

    Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.

    Product
    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
    Category
    Medical Device
    Distribution
    4 states