Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number:… — Class II medical device recall Z-3126-2024
Ongoing recall by Hitachi America, Ltd., Particle Therapy Division, reported 2024-09-18, distributed nationwide. During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float I
| Recall number | Z-3126-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi America, Ltd., Particle Therapy Division, Santa Clara, CA, United States |
| Recall initiated | 2024-05-27 |
| Classified | 2024-09-12 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 04560333350006 |
Product
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product 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. Component: N/A
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3126-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.