13
Jul
2005

Hitachi Medical Systems America Inc.

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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