Nov

2015

GE Centricity Universal Viewer Cl II

Company: GE Healthcare.
Date of Enforcement Report 11/11/2015
Class lI:

PRODUCT

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Recall Number Z-0226-2016

REASON
Inaccurate distance measurements with magnified projection X-ray images.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Barrington, IL on 9/28/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
Centricity Universal Viewer versions 6.0 and higher 5 units

DISTRIBUTION
Nationwide and Internationally

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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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GE Centricity Universal Viewer Cl II

Amy Sellers

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