Hitachi Echelon Oval MRI system is a diagnostic imaging device — Class II medical device recall Z-2564-2014
Terminated recall by Hitachi Medical Systems America Inc, reported 2014-09-10, distributed nationwide. The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
| Recall number | Z-2564-2014 |
|---|---|
| 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 | 2014-08-18 |
| Classified | 2014-09-02 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, DE, FR, JP |
| Quantity | 39 systems |
| Reason classes | device malfunction |
Product
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Reason for recall
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2564-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.