Company: Hitachi Medical Systems America Inc., Date of Enforcement Report:6/14/2006 Class:lI PRODUCT Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT), Recall # Z-1078-06 REASON The device has a software anomaly which affects the system’s ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at...Read More

Company:Hitachi Medical Systems America Inc., ., Date of Enforcement Report:6/14/2006 Class:lI PRODUCT Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). Recall # Z-1079-06 REASON The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference...Read More