Jun

2006

Class II Hitachi Medical Systems America Inc.

Company:Hitachi Medical Systems America Inc., .,
Date of Enforcement Report:6/14/2006
Class:lI

PRODUCT
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). Recall # Z-1079-06

REASON
The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized

CODE
CXR46201-46214 PC46002-46011

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006.
Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16 devices

DISTRIBUTION
Nationwide

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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