Home / Brands / Hitachi America, Ltd., Power Systems Division
Hitachi America, Ltd., Power Systems Division Recalls
2 recalls on record · July 29, 2015 to July 3, 2019 · Medical Devices
Recalls by year
15
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 3, 2019Medical DevicesFDA
Hitachi America, Ltd., Power Systems Division recalls PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Hazard: 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.
July 29, 2015Medical DevicesFDA
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
Hazard: 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.