---
title: "Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR — FDA record Z-1429-2026 | Is It on Recall"
description: "Software anomaly in the patient positioning system may result in positional discrepancy."
url: https://isitonrecall.com/recall/fda-device-z-1429-2026-brand-name-hitachi-proton-beam-therapy-system-ref-probeat-fr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR — FDA record Z-1429-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- **Reason**: Software anomaly in the patient positioning system may result in positional discrepancy.
- **Classification**: Class II
- **Recalling firm**: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- **Quantity**: 1
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1429-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1429-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution to states of: TX, Washington DC

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [District of Columbia](https://isitonrecall.com/state/district-of-columbia/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Mar 4, 2026
- **Recall initiation date**: Feb 6, 2026
- **Center classification date**: Feb 20, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1429-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha records](https://isitonrecall.com/brand/hitachi-ltd-radiation-oncology-systems-kashiwanoha/)