FDA Device recall Z-2564-2014
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiol…
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiol… by Hitachi Medical Systems America, citing the Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2564-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-18 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | US |
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
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Identifiers
| code_info | Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y1…Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2564-2014%22
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