Hitachi Echelon MRI System/Oasis MRI — Class II medical device recall Z-2254-2012
Terminated recall by Hitachi Medical Systems America Inc, reported 2012-08-29, distributed nationwide. Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an orig
| Recall number | Z-2254-2012 |
|---|---|
| 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 | 2012-06-15 |
| Classified | 2012-08-22 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 165 units |
| Reason classes | software |
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 for recall
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
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-2254-2012. 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.