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