Feb

2012

Cl ll Vitrea Enterprise Suite

Company:Vital Images, Inc.
Date of Enforcement Report 2/22/12
Class ll:

PRODUCT
Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. Recall # Z-0388-2012

REASON
Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated November 11, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
338 (233 US)

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 ll Vitrea Enterprise Suite

Amy Sellers

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