Class II — Hitachi America, Ltd., Particle Therapy Division
| Recalling firm | Hitachi High-Tech America, Inc. Radiation Therapy Division |
|---|---|
| Registered facility | HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V 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. Component: N/A |
| Quantity | 1 |
| Distribution | U.S. Nationwide distribution in the states of TN, TX, and WA. |
| Initiated | 2024-05-27 |
| Classified | 2024-09-12 |
| Recall number | Z-3127-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hitachi America, Ltd., Particle Therapy Division (Z-3127-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94928/
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