Hitachi America, Ltd., Power Systems Division

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1892-2019Class IIPROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.April 15, 2019
Z-1838-2015Class IIPROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medicalApril 21, 2015