# FDA recall Z-3125-2024

> **Hitachi America, Ltd., Particle Therapy Division** · Class II · device recall initiated 2024-05-27.

## Product

Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR 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.

## Distribution

U.S. Nationwide distribution in the states of TN, TX, and WA.

## Key facts

- **Recall number:** Z-3125-2024
- **Recalling firm:** Hitachi America, Ltd., Particle Therapy Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-27
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3125-2024

## Citation

> AI Analytics. FDA recall Z-3125-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-3125-2024. Source: US FDA. Licensed CC0.

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