4 results
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97ms
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Sources: EU EUDAMED, US FDA
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
FDA Recall
Terminated
·Hitachi America, Ltd., Power Systems Division·Product code LHN·April 15, 2019
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.
FDA Recall
Terminated
·Hitachi America, Ltd., Power Systems Division·Product code LHN·April 21, 2015
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.
FDA Enforcement
Class II
·Terminated·Hitachi America, Ltd., Power Systems Division·July 29, 2015
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
FDA Enforcement
Class II
·Terminated·Hitachi America, Ltd., Power Systems Division·July 3, 2019