Hitachi America, Ltd., Power Systems Division recalls PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

Recall date

April 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1892-2019

FDA classification

Class II

Brand / firm

Hitachi America, Ltd., Power Systems Division

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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