Company: Hitachi Medical Systems America IncDate of Enforcement Report: 6/16/04 Class: II PRODUCT Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04. REASON Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result...Read More

Company: Baxter Healthcare Renal DivDate of Enforcement Report: 6/16/04 Class: II PRODUCT a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04; b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013- 04. REASON A software...Read More