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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
Recalled July 29, 2015 · FDA recall Z-1838-2015 · Hitachi America, Ltd., Power Systems Division
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. · FDA Class II
Units
3
Sold at
Distribution in US (Texas) and Japan
Description
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.
Product
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.
Manufacturer(s)
Hitachi America, Ltd., Power Systems Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →