# FDA recall Z-1892-2019

> **Hitachi America, Ltd., Power Systems Division** · Class II · device recall initiated 2019-04-15.

## Product

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

## Reason for recall

There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

## Distribution

Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.

## Key facts

- **Recall number:** Z-1892-2019
- **Recalling firm:** Hitachi America, Ltd., Power Systems Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-15
- **Report date:** 2019-07-03
- **Termination date:** 2020-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2019

## Citation

> AI Analytics. FDA recall Z-1892-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1892-2019. Source: US FDA. Licensed CC0.

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