Hitachi Echelon MRI System — Class II medical device recall Z-1542-2017
Terminated recall by Hitachi Medical Systems America Inc, reported 2017-03-29, distributed nationwide. Image data transferred from the MRI system to a workstation showed errors on the slice position reference imag
| Recall number | Z-1542-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2015-04-16 |
| Classified | 2017-03-23 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, MX |
| Quantity | 68 units |
Product
Hitachi Echelon MRI System
Reason for recall
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.