FDA Device recall Z-2254-2012
Hitachi Echelon MRI System/Oasis MRI, Software
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Hitachi Echelon MRI System/Oasis MRI, Software by Hitachi Medical Systems America, citing hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2254-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-15 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | US |
Product
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Reason
Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu
Identifiers
| code_info | Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951 |
|---|
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-2254-2012%22
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