Hitachi America, Ltd., Power Systems Division
Hitachi America, Ltd., Power Systems Division appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1892-2019, Class II) was initiated on April 15, 2019.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1892-2019 | Class II | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. | April 15, 2019 |
| Z-1838-2015 | Class II | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical | April 21, 2015 |