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PROBEAT
HITACHI HIGH-TECH CORPORATION · Model PROBEAT-CR · UDI-DI 04560333350433
LHN
Prescription
1
510(k) clearances
136
Adverse events (2 deaths)
58
Recalls
27
Facilities
Description
The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site.
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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Get your free API keyRead the docsData 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.