Oct

2006

Class II Hitachi Medical Systems America Inc

Company: Hitachi Medical Systems America Inc.
Date of Enforcement Report:10/18/2006
Class:ll

PRODUCT
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007

REASON
Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

CODE
AIRIS – Serial Number Range: A001, AG001-AG039, A901; MRP-7000 – Serial Number Range: 7001- 7154..

RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on August 16, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
348 systems

DISTRIBUTION
Nationwide and PR

About the author

Amy Sellers

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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Class II Hitachi Medical Systems America Inc

Amy Sellers

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