FDA Device recall Z-1541-2017
Hitachi Echelon Oval MRI System
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Hitachi Echelon Oval MRI System by Hitachi Medical Systems America, citing image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1541-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | US |
Product
Hitachi Echelon Oval MRI System
Reason
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Identifiers
| code_info | Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1541-2017%22
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