Company: Hitachi Medical Systems America Inc.Date of Enforcement Report: 6/22/05 Class: II PRODUCT a) Hitachi Altaire Magnetic Resonance Imaging Device. Recall # Z-0888-05; b) Hitachi AIRIS II Magnetic Resonance Imaging Device. Recall # Z-0889-05; REASON Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. c) Hitachi...Read More