Hitachi America, Ltd., Power Systems Division Recalls

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

Class I - Dangerous

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.

Apr 15, 2019 Other Medical Devices View Details →

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.

Class I - Dangerous

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.

Apr 21, 2015 Infusion Pumps View Details →