I2C (IBA Image Guided Therapy Console)

IBIon Beam Applications SA · Model adaPTinsight

Image Guided Therapy Console.

Intended use: An automated device that is typically mounted on the gantry of a linear accelerator and intended to produce digital images of x-rayed anatomical landmarks to guide radiation treatment (e.g., tracking/targeting tumours). The device may be a digital imaging panel (e.g., of silicon) on robotic arms; it may also have an x-ray source to generate higher quality images.

Key tips

·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
·Run an incoming and annual electrical safety test regardless of how niche the device is.

PM Checklist

Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.

·Follow the manufacturer's PM schedule
·Perform incoming and annual electrical safety testing per facility biomedical program

Technical Specs

MRI safety: Labeling does not contain MRI Safety Information
Sterile: No
Single use: No
Prescription use: Rx only
FDA distribution status: In Commercial Distribution
Device type (GMDN): Radiation therapy digital imager
FDA product classification: System, Radiation Therapy, Charged-Particle, Medical

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

Varies by device - check the unit's own manual for facility placement guidance

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

RECALL
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.
RECALL
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
RECALL
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
RECALL
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
RECALL
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
RECALL
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
RECALL
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
RECALL
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

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