Mar

2017

Cl II Hitachi Oasis MRI System

Company: Hitachi Medical Systems America Inc
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Hitachi Oasis MRI System
Recall Number Z-1540-2017

REASON
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc., Twinsburg, OH on 4/16/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
210 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Cl II Hitachi Oasis MRI System

Amy Sellers

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