Hitachi America, Ltd., Particle Therapy Division

FDA Regulatory Profile

Hitachi America, Ltd., Particle Therapy Division appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3127-2024, Class II) was initiated on May 27, 2024.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3127-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A ProdMay 27, 2024
Z-3126-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A ProMay 27, 2024
Z-3125-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A ProMay 27, 2024