Day

October 18, 2006
Company: Hitachi Medical Systems America Inc. Date of Enforcement Report:10/18/2006 Class:ll PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol,...
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