Hitachi Healthcare Americas
Hitachi Healthcare Americas has 4 FDA recalls, 0 inspections, 17 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2339-2021 · Class II · Jul 29, 2021
- Latest 510(k)
- Oct 7, 2021
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 17 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2339-2021 | Class II | OASIS MRI System | Jul 29, 2021 |
| Z-2338-2021 | Class II | ECHELON Oval MRI System | Jul 29, 2021 |
| Z-2337-2021 | Class II | ECHELON MRI System | Jul 29, 2021 |
| Z-2308-2021 | Class II | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic… | Jun 30, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K211406 | OASIS MRI System | Oct 7, 2021 |
| K202422 | Arietta 65 | Nov 4, 2020 |
| K202030 | OASIS MRI System | Oct 21, 2020 |
| K200498 | SCENARIA View | Jul 17, 2020 |
| K192851 | OASIS MRI System | Feb 21, 2020 |
| K190841 | SCENARIA View | Sep 13, 2019 |
| K191233 | ARIETTA 750 | Aug 9, 2019 |
| K190248 | ARIETTA 50 | Apr 2, 2019 |
| K183291 | Supria True64 Whole-Body X-Ray CT System | Feb 1, 2019 |
| K183456 | Aloka Arietta 850 | Jan 28, 2019 |
| K172492 | Optical Topography System ETG-4100 | Aug 17, 2018 |
| K181376 | ARIETTA 65 | Jul 18, 2018 |
| K180901 | Low Dose CT Lung Cancer Screening Option | May 16, 2018 |
| K173739 | ALOKA ARIETTA 850 | Feb 28, 2018 |
| K172110 | ECHELON OVAL V6.0A MRI System | Jan 11, 2018 |
| K171708 | ALOKA ARIETTA 850 | Oct 31, 2017 |
| K171738 | Supria True64 | Aug 18, 2017 |