Hitachi America, Ltd., Power Systems Division recalls PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to pro…

Recall date

April 21, 2015

Source

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

Recall number

Z-1838-2015

FDA classification

Class II

Brand / firm

Hitachi America, Ltd., Power Systems Division

Sold / distributed

Distribution in US (Texas) and Japan

Why it was recalled

At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.

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 WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.