CLASS II Device recall · Reported 29 Aug 2012 · FDA Enforcement Report
Hitachi Echelon MRI System/Oasis MRI recalled by Hitachi Medical Systems
Hitachi Medical Systems America is recalling Hitachi Echelon MRI System/Oasis MRI, distributed nationwide in the US. The recall was initiated on 15 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2254-2012
- FDA event ID
- 62870
- Recalling firm
- Hitachi Medical Systems America, Twinsburg, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2012
- FDA classified
- 22 Aug 2012
- Reported
- 29 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 15 Jun 2012 | Recall initiated by company | |
| 22 Aug 2012 | Classified by FDA | +68 days |
| 29 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is Hitachi Echelon MRI System/Oasis MRI recalled?
Yes. Hitachi Medical Systems America recalled Hitachi Echelon MRI System/Oasis MRI on 15 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-2254-2012.
Why was it recalled?
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
Which lots are affected?
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
Where was it sold?
US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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