Hitachi Healthcare Americas Corporation
Hitachi Healthcare Americas Corporation appears in FDA public data with 4 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2338-2021, Class II) was initiated on July 29, 2021. Its most recent 510(k) clearance was granted on July 18, 2018.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2338-2021 | Class II | ECHELON Oval MRI System | July 29, 2021 |
| Z-2337-2021 | Class II | ECHELON MRI System | July 29, 2021 |
| Z-2339-2021 | Class II | OASIS MRI System | July 29, 2021 |
| Z-2308-2021 | Class II | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic | June 30, 2021 |