Recipient: Hitachi Medical Systems America Inc.Product: Magnetic Resonance Imaging Systems Date: 7/13/05 On April 20, 2004, your firm issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Your...Read More

Company: Baxter Healthcare Renal Div,Date of Enforcement Report: 7/13/05 Class: III PRODUCT Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R, Recall # Z-0947-05 REASON The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system. CODE All serial numbers with software version 4.0 or below RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare...Read More