# FDA recall Z-1429-2026

> **Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha** · Class II · device recall initiated 2026-02-06.

## Product

Brand Name: Hitachi Proton Beam Therapy System   Ref: PROBEAT-FR

## Reason for recall

Software anomaly in the patient positioning system may result in positional discrepancy.

## Distribution

US distribution to states of: TX, Washington DC

## Key facts

- **Recall number:** Z-1429-2026
- **Recalling firm:** Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-06
- **Report date:** 2026-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kashiwa, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2026

## Citation

> AI Analytics. FDA recall Z-1429-2026. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-1429-2026. Source: US FDA. Licensed CC0.

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