System, Radiation Therapy, Charged-Particle, Medical（LHN）

Software anomaly in the patient positioning system may result in positional discrepancy.

Software anomaly in the patient positioning system may result in positional discrepancy.

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.

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

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

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 of the treatment beam after the resume is delivered with an error in range

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

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.

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

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

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

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off