Company:achi Medical Systems America Inc
Date of Enforcement Report 8/29/12
Class ll:
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. Z-2254-2012
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 executing the MPR task.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc. Twinsburg, OH on 6/15/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
Nationwide and Mexico
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