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PROBEAT

HITACHI HIGH-TECH CORPORATION · Model PROBEAT WITH MGCS · UDI-DI 04560333350341

LHN Prescription

510(k) clearances

136

Adverse events (2 deaths)

Recalls

Facilities

Description

The PROBEAT with MGCS 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 only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treabment.

Recalls

Date	Firm	Reason
2026-02-06	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha	Software anomaly in the patient positioning system may result in positional discrepancy.
2026-02-06	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha	Software anomaly in the patient positioning system may result in positional discrepancy.
2026-02-03	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
2024-07-10	Ion Beam Applications S.A.	Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
2024-07-08	Ion Beam Applications S.A.	Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
2024-05-27	Hitachi America, Ltd., Particle Therapy Division	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
2024-05-27	Hitachi America, Ltd., Particle Therapy Division	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
2024-05-27	Hitachi America, Ltd., Particle Therapy Division	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
2024-05-10	Ion Beam Applications S.A.	Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
2024-03-04	Ion Beam Applications S.A.	There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.