Company: Hitachi America, Ltd., Power Systems Division
Date of Enforcement Report: 7/3/2019
Class II

PRODUCT

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

Recall Number: Z-1892-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Hitachi America, Ltd., Power Systems Division on 7/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION

US Nationwide and International