Reported Aug 29, 2012 · Terminated
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon…
Hitachi Medical Systems America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087
Is this the product you have?
- Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices
- Product UsageThe 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
- Lot codes and dates
- Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
- Amount recalled
- 165 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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