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Ion Beam Applications S.A Recalls
36 recalls on record · April 30, 2014 to March 18, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 24, 2017Medical DevicesFDA
Ion Beam Applications S.A. recalls Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam f
Hazard: 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.
April 26, 2017Medical DevicesFDA
Ion Beam Applications S.A. recalls Proteus 235, Proton Therapy System
Hazard: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
April 5, 2017Medical DevicesFDA
Ion Beam Applications S.A. recalls Proteus 235
Hazard: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
December 31, 2014Medical DevicesFDA
Ion Beam Applications S.A. recalls adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation th
Hazard: 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 mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du
November 5, 2014Medical DevicesFDA
Ion Beam Applications S.A. recalls Proteus 235 Proton Therapy System for cancer treatment.
Hazard: 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 accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
April 30, 2014Medical DevicesFDA
Ion Beam Applications S.A. recalls Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton the
Hazard: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).