ION BEAM APPLICATIONS S.A.

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 ri…

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

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

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 …

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 …

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

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

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

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 fi…

There is a risk of detachment of the Compact Gantry Rolling Floor.

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.

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.

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. …

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.

There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

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.

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

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.

Software issue

IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

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.

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

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 collis…

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 posit…

Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).