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 firm became aware of the co-mingling problem when you received complaints from two different customers stating that images from one patient’s study were co-mingled with another patient’s study. Both complaints also stated that the images were captured under one patient file (Complaint #’s 1-962SL and IATAW5).

FDA District: Cincinnati District Office